Friday, January 28, 2011

FDA and Triad Alcohol Prep Pads News

Image representing Pfizer as depicted in Crunc...Image via CrunchBaseFrom the FDA this week:

Pfizer Inc. and Progenics Pharmaceuticals, Inc. have learned of a United States market recall of alcohol prep pads and swabs manufactured by the Triad Group. In the interest of patient safety, Pfizer and Progenics are alerting U.S. patients and physicians to Triad’s recall. Triad® Alcohol Prep Pads are packaged for use with the kit presentation of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.

Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their RELISTOR injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.

Shipments of RELISTOR kits have been suspended until the alcohol pads can be replaced, which will be done as quickly as possible to enable patients to continue to receive RELISTOR. Triad alcohol prep products are not included in RELISTOR sold as single vials or in RELISTOR kits outside of the United States or with other Pfizer medications.

For more go hereFD. 
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