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FDA Drug & Medical Device Recall News & Comments 
Wednesday, January 19 2011


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED   

Refer to MIN 11 - 10

Ken Evenstad
Chairman/Chief Executive Officer
Upsher Smith Laboratories, Inc.
6701 Evenstad Drive
Maple Grove, Minnesota  55369

Dear Mr. Evenstad:

This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.slo-niacin.com/1 and has determined that your SLO-NIACIN® product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your website establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  The marketing of this product with these claims violates the Act.  You may find the Act and the FDA's regulations through links on FDA's home page at http://www.fda.gov/2.

Examples of some of the claims observed on your website include:

  • "SLO-NIACIN.Reduced risk of cardiovascular events* when combined with a statin."
  • "SLO-NIACIN.Halted stenosis progression when combined with a statin."
  • "Niacin is clinically proven to help manage cholesterol levels, a major factor in heart health.
  • "SLO-NIACIN® Offers an affordable option for Cholesterol Management.
  • "[N]iacin is the oldest of today's commonly used agents for lowering cholesterol."
  • "See how.niacin complements statin therapy for heart health."

Furthermore, the "References" and "In the News" sections of your website for this product cite a number of articles about the usefulness of the ingredient niacin in treating and preventing diseases.  When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use.  For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.  The following are examples of reference citations used to market your product for disease treatment and prevention on your website:

  1.  "Lavie CJ, Mailander L, Milani.  Marked benefit with sustained-release niacin therapy in patients with ?isolated' very low levels of high-density lipoprotein cholesterol and coronary artery disease.  Am J Cardiol.  1992; 69:1083-1085."
  2.  "Gray DR, Morgan T, Chretien SD, Kashyap ML.  Efficacy and Safety of Controlled-Release Niacin in Dyslipoproteinemic Veterans.  Ann Intern Med. 1994; 121:252-258."
  3. "Brown BG, Zhao XQ, Chait A, et al.  Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.  N Engl J Med. 2001; 345(22):1583-1592."
  4. "Knopp RH, Retzlaff BM, Fish B, et al.  The SLIM study: Slo-Niacin and atorvastatin treatment of lipoproteins and inflammatory markers in combined hyperlipidemia.  J Clin Lipidol.  2009; 3(3):167-178."

Your product is not generally recognized as safe and effective for the above referenced uses and therefore the product is a new drug as defined in section 201(p) of the Act, 21 U.S.C. § 321(p). Under section 505(a) of the Act, 21 U.S.C. § 355(a), a new drug may not be legally marketed in the United States without prior approval from FDA.  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your SLO-NIACIN product is also misbranded within the meaning of section 502(f)(1) of the Act in that the labeling for this drug fails to bear adequate directions for use, 21 U.S.C. § 352(f)(1).

The above violations are not meant to be an all-inclusive list of deficiencies in your product and its labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.  The Act authorizes the seizure of illegal products and injunction against manufacturers and distributors of those products, 21 U.S.C. §§ 332 and 334.

We note that you provide several images on your website at the Internet address http://www.slo-niacin.com/3.  Under 21 CFR 101.93(g)(2)(iv)(E), an image may be considered as a claim to diagnose, mitigate, treat, cure, or prevent disease if in the context of the labeling it suggests that the product has an effect on a disease or diseases.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to ensure similar violations do not occur. You should include in your response documentation such as revised labeling or other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, state the reason for the delay and the time frame within which any remaining violations will be completed.

Your written response should be directed to the U.S. Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address listed in the letterhead.  If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely, 

 

/S/

Gerald J. Berg
Director
Minneapolis District

Posted by: DW AT 09:48 am   |  Permalink   |  Email
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
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This is an Attorney / Lawyer Advertising Website. It is not a medical information, medical dictionary, medical advice or medical help site. Talk to you own treating Doctor about any questions or concerns that you have concerning any medicine, drug, medical device or treatment plan. Do not rely on any information on this site to alter, stop or change any medication or treatment plan by your prescribing or treating Doctor. Many of the drugs and devices listed here on this site have published risk and warnings associated with their use and have not been recalled. This website is not in anyway connected with any drug company or the FDA.Check with your Doctor, Pharmacy and/or the FDA as to any concerns as to their use, recall status and safety. See http://www.fda.gov/ for the latest information.

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