notyard
08-22-2009, 01:07 PM
FDA class II recall:
PRODUCT
Fenoglide (fenofibrate) tablets, 120 mg, 7 tablet Professional Sample bottle, Rx only; NDC 59630-495-07, Recall # D-1889-2009
CODE
Lot # 0802584, Exp 10/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sciele Pharma, Inc., Atlanta, GA, by letters on July 10, 2009, July 13, 2009 and August 10, 2009.
Manufacturer: Catalent Pharma Solutions LLC, Winchester, KY. Firm initiated recall is ongoing.
REASON
The product may lack efficacy due to the Out of Specification dissolution result at the 9-month stability pull point.
VOLUME OF PRODUCT IN COMMERCE
58,176 units (7 count bottles)
DISTRIBUTION
Nationwide
PRODUCT
Fenoglide (fenofibrate) tablets, 120 mg, 7 tablet Professional Sample bottle, Rx only; NDC 59630-495-07, Recall # D-1889-2009
CODE
Lot # 0802584, Exp 10/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sciele Pharma, Inc., Atlanta, GA, by letters on July 10, 2009, July 13, 2009 and August 10, 2009.
Manufacturer: Catalent Pharma Solutions LLC, Winchester, KY. Firm initiated recall is ongoing.
REASON
The product may lack efficacy due to the Out of Specification dissolution result at the 9-month stability pull point.
VOLUME OF PRODUCT IN COMMERCE
58,176 units (7 count bottles)
DISTRIBUTION
Nationwide