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FDA Drug & Medical Device Recall News & Comments 
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
Monday, October 05 2009

 

Potentially Fatal Errors with Certain Glucose Test Strips

WARNING: FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.

FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin, such as Extraneal. A more specific product list can be found below.

The problem is that some glucose meters use a type of test strip (GDH-PQQ) that cannot distinguish between glucose and these other sugars, so the reading on one of these test strips will reflect both the patient's actual blood glucose and the other sugar the patient received. These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration. This can result in severe hypoglycemia, coma and death. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars.

FDA has received 13 reports of deaths associated with GDH-PQQ test strips that had documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated blood sugar results. Six of the 13 deaths have occurred since 2008, despite previous warnings from FDA and others. See: GDH-PQQ Glucose Test Strip Recall Warning by FDA

FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.

If a facility does use GDH-PQQ test strips, FDA recommends additional precautions: 

*  Determine whether patients are receiving products that contain other sugars when they are admitted and periodically during their stay at the facility.

* If patients are receiving one of these interfering products, never use GDH-PQQ test strips to monitor their blood glucose. Instead, use only laboratory-based glucose assays. This also holds true for patients who are unresponsive or cannot communicate adequately. 

* Educate the staff about this potentially fatal problem, and consider safeguards such as drug interaction alerts in computer order entry systems, patient profiles and charts. And for patients who are not receiving interfering products, periodically verify glucose meter readings with laboratory-based results.

FDA is working with glucose monitoring manufacturers to address problems with GDH-PQQ glucose test strips, and will continue to monitor adverse events associated with these products.

FDA RECALL NEWS - Oct. 5, 2009

Posted by: DW AT 01:33 pm   |  Permalink   |  Email
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