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FDA Drug & Medical Device Recall News & Comments 
Thursday, January 13 2011

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. 

Jan. 13, 2011 

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, Q&As, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239955.htm
Posted by: DW AT 12:41 pm   |  Permalink   |  Email
Tuesday, January 11 2011

WARNING LETTER


VIA UPS EXPRESS

JAN 11 2011

Paula Morgan, RAC
Senior Director, Regulatory Affairs
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
       
Dear Ms. Morgan:

The Food and Drug Administration (FDA) cleared under premarket notification your Zodiac DynaMo Semi-Rigid Spinal System (K072081), ISOBAR Semi-Rigid Spinal System (K991326), and ISOBAR Semi-Rigid Dual Dampener (K071261).  On October 5, 2009, FDA ordered your firm to conduct postmarket surveillance of your Zodiac DynaMo Semi-Rigid Spinal System, your ISOBAR Semi-Rigid Spinal System, and your ISOBAR Semi-Rigid Dual Dampener, in accordance with section 522 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 360l, and 21 CFR Part 822. 

On July 30, 2010, FDA notified you that after evaluating your section 522 postmarket surveillance study protocol, FDA concluded that your submission lacked information needed to complete the review.  FDA listed the deficiencies with your protocol and required a complete response within 30 days.  On September 10, 2010, FDA issued a follow-up letter stating that FDA had not received your section 522 postmarket surveillance study protocol and required the overdue postmarket surveillance study plan within 14 days.    

After FDA issued the approvable letter identifying the specific revisions or information that must be submitted before your plan can be approved, you failed to revise your postmarket surveillance submission to address the concerns in the approvable letter and submit it to FDA within the specified timeframe, under 21 CFR 822.19(b). Under section 502(t)(3) of the Act, 21 USC 352(t)(3), your devices are misbranded because you failed or refused to comply with any requirement under section 522 of the Act, 21 USC 360l.  

You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.  Please note that Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Within fifteen (15) working days from the date you receive this letter, please submit your section 522 postmarket surveillance study plan that addresses the deficiencies identified in the July 30, 2010, letter, and notify this office in writing of the specific steps you have taken to correct the noted violation.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your study plan and response to this letter should be sent to: 

Attention:  Mary Beth Ritchey, RN, MSPH, PhD
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Building 66, Room 4274
Silver Spring, Maryland 20993-0002.

If you have any questions about the content of this letter please contact: Mary Beth Ritchey at 301-796-6638 (telephone) or 301-847-8140 (fax).  

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices.  This letter pertains only to the issue of postmarket surveillance requirements for your devices and does not necessarily address other obligations you have under the law.

Sincerely yours,

/s/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and 
Radiological Health

Posted by: DW AT 09:52 am   |  Permalink   |  Email
Wednesday, January 05 2011

Inter-Ocean Seafood Traders Inc

January 05, 2011

VIA UPS 
 
John W. Chen, Owner/Operator
Inter-Ocean Seafood Traders, Inc.
1200 Industrial Road, Suite 12
San Carlos, CA 94070-4129
 
Warning Letter
 
Dear Mr. Chen:
 
We inspected your seafood importer establishment, located at 1200 Industrial Road, Suite 12, San Carlos, California, on November 15-17, 2010.  We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your frozen shrimp and prawns are adulterated under Section 402(a)(4)of the Act, 21 U.S.C. 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at http://www.fda.gov/1.
 
Your significant violations are as follows:
  1. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i).   However, your firm imports shrimp from Ecuador, Nicaragua and Indonesia and you do not have product specifications to address the hazard of undeclared sulfites.
  1. You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the importation of frozen shrimp imported from any of your foreign suppliers to address the hazard of undeclared sulfites.

We may take further action if you do not promptly correct this violation. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

Please send your written reply to the Food and Drug Administration, Attention: Sergio Chavez,Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.

Sincerely,
/S/
Barbara J. Cassens
District Director
Posted by: DW AT 09:43 am   |  Permalink   |  Email
Tuesday, December 28 2010

December 28, 2010

WARNING LETTER

Via UPS


Kelly D. Harvey, President
NovaCare, LLC (TSN Labs, Inc.)
330 West 6100 South
Salt Lake City, UT  84047

Ref: # DEN-11-06-WL

Dear Mr. Harvey:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above from March 8, 2010 through March 22, 2010.  During the inspection samples were collected of your firm's (b)(4) an ingredient used by your firm in the manufacture of products marketed as dietary supplements, and of the Master Manufacturing Records for products manufactured by your firm, which show (b)(4) as a component in their production.  Laboratory analyses conducted by the FDA concluded that your firm's (b)(4) contains sulfoaildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED).  Following this finding, FDA obtained samples of products manufactured by your firm and marketed as dietary supplement including, but not limited to, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX,"  "Zilex," and "Zotrex."1   For the reasons stated below, these  products are unapproved drugs in violation of section 505(a) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(a)] and misbranded drugs in violation of sections 502(f)(1) [21 U.S.C. 352(f)(1)], 502(f)(2) [21 U.S.C. 352(f)(2)] and 502(a) [21 U.S.C. 352(a)].  In addition, [(b)(4) is a drug within the meaning of section 201(g)(1)(D) [21 U.S.C. 321(g)(1)(D)] of the Act and is misbranded under section 502(f)(1) [21 U.S.C. 352(f)(1)] of the Act.  

Your firm's sexual enhancement products "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are labeled with claims such as the following:

"Aziffa"

? "Male Sexual Stimulant"
? "Sexual Stimulation Blend"

 "MONSTER EXCYTE"

? "INCREASED SEX DRIVE, STAMINA AND VIRILITY FOR MEN"
? "MALE SEXUAL VITALITY ENHANCER"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"

"Natural WOW! Ultra Perform for MEN"

? "SEXUAL BOOSTER!"
? "INCREASES STAMINA"
? "BOOSTS SEXUAL APPETITE"
? "INCREASES SEXUAL VITALITY"
? "take one capsules 30-45 minutes before sexual activity"

"Natural WOW! Ultra Perform for WOMEN"

? "SEXUAL BOOSTER!"
?  "BOOSTS SEXUAL APPETITE"
? "INCREASES FEMALE SEXUAL VITALITY"
? "take one capsules 30-45 minutes before sexual activity"

"OMG"

? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"
? "OMG Vitality Formula"

"ProLatis'"

? "All-Natural Male Performance Pill"
? "Take 1-2 capsules 1-2 hours before sexual activity."

"Stiff Nights"

? "Male Sexual Stimulant"
? "Regain the Thunder"
? "Erection Booster BlendTM"

"Verect"

? "Male Sexual Vitality"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity."
? "Zotrex Vitality Formula"

"XaitriX"

? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"

"Zilex"

? "Female Sexual Vitality"
? "Zilex Vitality Formula"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water."

"Zotrex"

? "Male Sexual Vitality"
? "Zotrex Vitality Formula"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water"

These statements make clear that the above mentioned products are drugs under section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)] because they are intended to affect the structure or function of the human body.  Your firm's "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" sexual enhancement products are labeled as dietary supplements.  However, these products contain sulfoaildenafil, a phosphodiesterase type 5 (PDE5) inhibitor and an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED).  Sulfoaildenafil is a synthetic active pharmaceutical ingredient and is not a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)].

Under section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)] or the product is subject to regulation as a drug.  Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body.  However, the structure/function claims quoted above do not describe the effects of nutrients or dietary ingredients in the products.  Rather, the claims are made for the products as a whole and relate to their sulfoaildenafil content.  Since sulfoaildenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)], but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)].  Accordingly, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are drugs within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)].

Furthermore, under section 201(g)(1)(D) of the Act [21 U.S.C. 321(g)(1)(D)], an article intended for use as a component of a drug is also a drug.  Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.  See Title 21 of the Code of Federal Regulations, Part 210.3(b)(3) [21 CFR 210.3(b)(3)].  Master Manufacturing Records obtained from your firm indicate that (b)(4) is an ingredient used in the manufacture of drugs, including, but not limited to "Zotrex."  Accordingly, your firm's (b)(4) is a drug within the meaning of section 201(g)(1)(D) of the Act [21 U.S.C. 321(g)(1)(D)]. 

Moreover, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are new drugs, as defined by section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.  Under sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.  Your distribution or sale of these products without an approved application violates these provisions of the Act.

"Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are "prescription drugs" as defined at section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)] because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them.  Indeed, all FDA approvals of PDE5 inhibitors are limited to use under the professional supervision of a practitioner licensed by law to administer such drugs.

According to section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s).  "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR 201.5]. 

Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner.  Therefore, it is impossible to write "adequate directions for use" for prescription drugs.  FDA-approved drugs that bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson [21 U.S.C. 201.100(c)(2) and 201.115].  Because there is no FDA-approved application for "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex," their labeling fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

In addition, a drug in bulk package form intended for use in the manufacture of a new drug is only exempt from section 502(f)(1) of the Act [21 CFR 352(f)(1)] if it satisfies the specific conditions set forth in 21 CFR 201.122.  Your bulk package drug (b)(4) does not satisfy the conditions of the exemption. Thus, your firm's (b)(4) is also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

Under section 502(a) of the Act [21 U.S.C. 352(a)], a drug is misbranded if its labeling is false or misleading in any particular.  Section 201(n) of the Act [21 U.S.C. 321(n)] provides that in determining whether a drug's labeling or advertising "is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts material in light of such representations . . . ."  The labeling of the above mentioned products does not declare that they contain sulfoaildenafil.  Sulfaoaildenafil is an analogue of sildenafil, and, like sildenafil, is a PDE5 inhibitor.  Because it is an analogue of sildenafil, sulfoaildenafil likely exhibits similar pharmacological action to sildenafil.  The use of PDE5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events.  The undeclared PDE5 inhibitor in the above mentioned products may pose a serious health risks because patients with underlying medical issues may take these products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking.  For example, PDE5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  Further, patients who have been advised against taking PDE5 inhibitors because of comorbidities or potential drug interactions may seek products like "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" because they are marketed as not containing the active ingredients in approved ED drugs.  The failure to disclose the presence of sulfoaildenafil renders your products' labeling false and misleading.  "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are therefore misbranded under Section 502(a) of the Act [21 U.S.C. 352(a)]. 

"Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are also misbranded under Section 502(f)(2) of the Act, [21 U.S.C. 352(f)(2)] in that their labeling lacks adequate warnings for the protection of users.  As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes them would be unaware of the presence of sulfoaildenafil.  For example, because sulfoaildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" may be at risk of life-threatening hypotension.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act (21 U.S.C. 331).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your reply should be sent to the Food & Drug Administration, Denver District Office, Denver Federal Center - Building 20, 6th Avenue and Kipling Street, P.O. Box 25087, Denver, CO 80225-0087, to the attention of Thomas R. Berry, Compliance Officer.  If you have any questions regarding the content of this letter, please contact Mr. Berry at (303) 236 -3028.

 

Sincerely,

/s/

H. Thomas Warwick, Jr.
Denver District Director

Posted by: DW AT 09:55 am   |  Permalink   |  Email
Thursday, December 16 2010

WARNING LETTER - PROGRAM DISAPPROVAL

Dec. 16, 2010

Mr. Ronald Poe, Owner
Mega Sun, Inc.
4515 Miami St.
Saint Louis, MO 63116-1707

Dear Mr. Poe:

This letter notifies you that the United States' Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), hereby disapproves the quality control and testing program for your firm's sunlamp products including, but not limited to Models Megasun Slimline, Megasun Extreme, Megasun Crossfire and Megasun Mega V produced by Mega Sun, Inc., Saint Louis, MO. This action is taken under the authority of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C Electronic Product Radiation Control, Section 534(h) [U.S.C. 360kk(h)].

This disapproval means that your firm is prohibited by Sections 534(h) and 538(a) of the Act from:

1. Certifying the electronic products manufactured under the disapproved testing program ( 538(a)(5)(B)),

2. Introducing, delivering for introduction, or importing into U.S. commerce any product which does not comply with the applicable standard ( 538(a)(1)), and

3. Introducing or importing into U.S. commerce any product which does not have a certification as required by section 534(h) and ( 538(a)(5)(A)).

A significant failure to comply with the requirements of the applicable performance standards was discovered during review of an establishment inspection report submitted by Ms. Kelly Sheppard and Mr. Eric Padgett, investigators of the FDA's Kansas District Office. Ms. Sheppard and Mr. Padgett's report was based on their July 27 and August 11, 2010 inspections of Mega Sun, Inc. Based on the findings listed below, CDRH finds that Mega Sun, Inc. failed to establish a quality control and testing program which ensures compliance with the applicable performance standards. Sunlamp products  manufactured on or after May 7, 1980, are subject to the requirements of the Federal performance standard for sunlamp products (Title 21 CFR 1040.20) as well as the general performance standard for electronic products (Title 21 CFR 1010). Mega Sun, Inc. has also failed to comply with requirements for reports and record keeping (Title 21 CFR 1002).

Specifically, your sunlamp products fail to comply with:

1. 21 CFR 1010.2(c) Certification

a. The firm's sunlamp products failed to be certified based upon a quality control and testing program in accordance with good manufacturing practices. Specifically, because your firm did not maintain any manufacturing quality control or test records for sunlamp products entered into commerce, there is no evidence that an adequate quality control and testing program exists which ensures your sunlamp products comply with the performance standard.

You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of sunlamp products which have been produced and the number of such products that have left the place of manufacture.

Additionally, you have 15 days after you receive this letter to respond in writing using one of the options listed below:

1. Refutation. Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.

2. Exemption Request. Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements (21 CFR 1003.10(b)). If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.

3. Purchaser Notification and Corrective Action. If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.

a. Notification Letter. Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the  notification letter(s) sent to purchasers and dealers must also be sent to the FDA. We recommend that you submit a draft of this letter to us for review.

b. Corrective Action Plan (CAP). Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must
expeditiously correct the failure to comply with the performance standard and must be approved as set out in 21 CFR 1004.6.

If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11 (c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.

The following failures to comply with regulations regarding reports and record keeping were noted during a review of the establishment inspection report prepared by the FDA's Kansas District Office and a review of our records:

1. 21 CFR 1002.30(a)(1), 1002.30(a)(2), 1002.30(a)(4) Records to be maintained by manufacturers. The firm failed to maintain the following records:

a. Description of the quality control and testing procedures with respect to electronic product.

b. Results of tests for electronic product radiation safety including the control of unnecessary, secondary or leakage of radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.

c. Copies of communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed products.

2. 21 CFR 1002.10, 1002.11 Product reports, Supplemental reports. The firm failed to submit a product or supplemental report for each sunlamp product model or model family it manufactured and entered into commerce.

3. 21 CFR 1002.13 Annual Reports. The firm failed to submit annual reports for products it manufactured and entered into commerce.

Section 538(a) of the Act, Chapter V, Subchapter C Electronic Product Radiation Control prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the performance standard. It is also a prohibited act to fail to establish and maintain required records and failure to submit required reports. Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.

In summary, to address these violations you must:

1. Submit a corrective action plan that addresses the failure to certify sunlamp products based on a quality control testing program as required by 21 CFR 1010.2(c) Certification. As indicated above you may refute the failures to comply and/or request an exemption from your responsibility to notify dealers, distributors and purchasers as described above. The regulations associated with each of these options lists the specific information required to provide a complete response.

In order for FDA to evaluate plans to correct your quality control testing program, you must provide the following items in your response:

1. A complete description of the quality control testing program, to include policies, procedures, forms and other documentation, you will use to certify your sunlamp products prior to entering those products into commerce. Include at least one set of test data and quality control records that were generated using the submitted procedures. Your quality control testing program must be documented by submission of a product or supplemental report as required by 21 CFR 1002.10 and 1002.11.

2. Documentation that your quality control testing program ensures safety and compliance of all models of sunlamp products which you intend to enter into commerce. If different models have unique features that create differences in radiation emission characteristics, how they comply with the sunlamp standard or how they are tested, your quality control testing program must account for those differences. Information on models having such unique features must be documented separately in supplemental reports as required by 21 CFR 1002.11.

3. Photographs depicting implementation of your quality control testing program at your factory. At a minimum these photographs must depict the following testing for each model of sunlamp product you currently produce:

? spectral measurements of emissions to ensure the exposure timer settings are accurate,
? calibration of each piece of test equipment (if you don't calibrate your own instruments provide a copy of outside calibration report(s)),
? use of test equipment during product compliance testing,
? placement of each required label, and
? use of the quality control form(s) used to record compliance with each of the performance standard's requirements.

In order for FDA to evaluate plans to notify purchasers and repair, replace or refund products already introduced into commerce, you must provide the following items in your response:

4. Distribution records to indicate number of sunlamp products produced and the number of such products that left the place of manufacture since you began introducing products into the US. Submit annual reports covering all models of sunlamp products entered into commerce over the last 5 years in order to bring your annual reporting up-to-date as required by 21 CFR 1002.13. Annual reports must include any communications with customers, service personnel, dealers, distributors, or regulatory agencies that reference radiation safety or radiation emissions.

5. A draft customer notification and CAP to bring products previously entered into commerce into compliance. At a minimum, your CAP should include a procedure for verifying that distributed products comply with all applicable requirements of the performance standards (21 CFR 1010 and 1040.20). The procedure must include a means of creating and maintaining a record of the tests and inspections made that confirm each product complies with all applicable requirements of the performance standard.

The CDRH will review this information and advise you whether your corrective actions are satisfactory. You may not resume introduction of sunlamp products into commerce until you establish an adequate quality testing program, complete any necessary production changes to assure compliance of all units to be entered into commerce, submit all required reports and report supplements, and receive written notification that CDRH approves your plans to correct quality testing program deficiencies. Further, it is possible that CDRH will not approve your plan or will require additional actions; therefore, we recommend that you do not pursue correction of products already entered into commerce until you receive written notification that CDRH approves your plans to bring those products into compliance.

Copies of the Federal Performance Standards, compliance guides, radiation safety lproduct report guides, and other documents related to sunlamp products are available on FDA's web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm1.

Your response should be sent to:

Chief, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., W066-4621
Silver Spring, Maryland 20993-0002

If you have any questions regarding the content of this letter, you may contact Sharon Miller, Electronics Engineer at (301) 796-2471 or by email to SharonA.Miller@fda.hhs.gov.

Sincerely,

/s/

Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health

Posted by: DW AT 09:57 am   |  Permalink   |  Email
Thursday, December 02 2010

WARNING LETTER

DEC. 2, 2010

VIA UNITED PARCEL SERVICE & FACSIMILE

Mr. Michael Plew
Vice President of Quality and Regulatory Compliance
LifeNet Health
1864 Concert Drive
Virginia Beach, VA 23453

RE: MatrACELL Pulmonary Artery Patch Allograft

Dear Mr. Plew:

Refer to CMS #128430 when replying to this letter

The Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your July 27, 2010 response to our letter, dated July 14, 2010, regarding promotional claims made for the MatrACELL? Pulmonary Artery Patch Allograft (MatrACELL? Allograft). FDA has determined that your response is inadequate and that your firm is marketing the MatrACELL? Allograft in the United States (U.S.) for a new intended use without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA reviewed your website, http://www.lifenethealth.org/1, for the MatrACELL? Allograft on July 14, 2010. The MatrACELL? Allograft is a device within the meaning of Section 201(h) of the Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. 
 
As we noted in our letter dated July 14, 2010, your promotional materials, which appear on your website at http://www.lifenethealth.org/2, promote the MatrACELL? Allograft for the claim of "reduced immune response." FDA cleared your premarket notification (510(k)) for the MatrACELL? Allograft, K081438, for repair of the right ventricular outflow tract. However, the MatrACELL? Allograft has not been cleared for the claim of "reduced immune response."  This claim represents a major change or modification in the intended use of your device that requires a new premarket notification. 21 CFR 807.81(a)(3)(ii).
 
The MatrACELL? Allograft is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e (a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for the new intended use discussed above, as required by sections 510(k) of the Act, 21 U.S.C. 360(k) and 21 CFR 807.81(a)(3)(ii).
 
FDA requests that LifeNet immediately cease marketing the MatrACELL? Allograft for unapproved uses such as those described above.  You should take prompt action to correct these violations.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
 
We suggest LifeNet Health contact the Peripheral Vascular Devices Branch, Office of Device Evaluation at (301) 796-6376 to discuss the submission of a premarket notification (510(k)) for any proposed new intended use of the MatrACELL  Allograft.
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for MatrACELL? Allograft containing claims for unapproved uses such as those described above, and explain your plan for discontinuing use of such claims.  Please direct your response to Daniel G. Walter, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B, WO66, Room 3678, Office of Compliance, at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, facsimile at (301) 847-8139.  We remind you that only written communications are considered official.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for MatrACELL? Allograft comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiologial Health

Posted by: DW AT 10:00 am   |  Permalink   |  Email
Monday, November 09 2009

Edwards Lifesciences Corporation, CardioVations EndoClamp Aortic Catheter
Recall Class: Class I
Date Recall
Initiated: September 24, 2009
Product: CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65

This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.
 
Use: The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
Recalling Firm: Edwards Lifesciences Corporation
6864 South 300 West
Midvale, Utah 84047
Reason for Recall: The balloon catheters may spontaneously rupture during surgery.
Public Contact: Customers may contact the company's Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. - 4:30 p.m., Pacific Time.
FDA District: Denver
FDA Comments: On October 29 , 2009, the company sent a follow up letter to their customers instructing them to:

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Posted by: DW AT 10:37 pm   |  Permalink   |  Email
Wednesday, October 21 2009

American Regent Voluntarily Recalls All Lots of Ketorolac
Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

FOR IMMEDIATE RELEASE - October 20, 2009 - Shirley, NY - American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

 NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial

 NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL) 

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site. 

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return. 

"Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks," said Mary Jane Helenek, President and CEO of American Regent. 

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25. 

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency. 

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit"

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET. 

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000. 

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178]. 

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Ketorolac Tromethamine Injection Injury Lawsuit

If you or a loved one have have been injured had serious injury as a result of a recalled or defective Ketorolac Tromethamine Injection, then call us to discuss your legal rights to monetary compensation for your injuries or the death of a loved one. The Willis Law Firm has represented thousands of clients across the United States in defective and recalled medical devices, recalled drugs and other product liability claims. Mr. Willis is a Board Certified Trial Lawyer with 25+ years of legal experience. Call us at 1-800-883-9858 or fill out our online case form.

 

Posted by: DW AT 03:29 pm   |  Permalink   |  Email
Friday, October 09 2009

[Posted 10/09/2009] FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level. While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.

FDA encourages every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index and the dose-length product. For each protocol selected, and before scanning the patient, carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned. Patients should follow their doctor's recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks.

Read the MedWatch safety summary, including a link to the FDA Initial Notification, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm 


Posted by: dw AT 01:50 pm   |  Permalink   |  Email
Wednesday, October 07 2009

Neuron 6F 070 Delivery Catheter [Penumbra]

[UPDATED 10/07/2009] Recall classified as Class I.

[Posted 10/01/2009] Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death. There are four injury reports to date, which may be potentially associated with this defect.

Facilities that have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device.  Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. The affected product catalog numbers and lot numbers are provided in the firm press release.

Penumbra, Inc. Neuron 6F 070 Delivery Catheter (Original Version)

Recall Class: Class I
Date Recall
Initiated:
September 22, 2009
Product: Penumbra Neuron 6F 070 Delivery Catheter (Original Version)
Catalog Numbers Lot Numbers
PND6F0701058, PND6F0701058M, PND6F070956,
PND6F070956M
F13773, F13799, F13733, F13751, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, F14629
This product was distributed from November 2008 to May 2009.
Use: The Neuron 6F 070 Delivery Catheter is a component of the Neuron Intracranial Access System, which is used by physicians to introduce medical devices into blood vessels.
Recalling Firm: Penumbra, Inc.
1351 Harbor Bay Parkway
Alameda, California 94502-6541
Reason for Recall: The device may kink and/or break which may lead to longer surgery times, patient injury or death.
Public Contact:

Consumers may contact the company at 1-888-272-4606 or 1-510-748-3200, Monday - Friday, 8 AM to 5 PM Pacific Time.

For more information, see Useful Links below.

FDA District: San Francisco
FDA Comments:

On September 22, 2009, the company sent their customers a field removal letter requesting that they inspect their stock, remove all affected devices and return them to the company. The company will replace the affected devices. The company also asked their customers to complete and sign a product identification/return form.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Posted by: DW AT 04:20 pm   |  Permalink   |  Email

Willis Law Firm - Houston, Texas Drug Injury Lawyer and Attorney Free Lawsuit & Class Action Lawsuit Lawyer

 

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