The FDA has released the following information.
PRODUCT
Glucophage XR tablets (metformin HCl extended release), 500 mg, 100 count bottles, Rx only, Distributed by: Bristol-Myers Squibb Company, Princeton, NJ, NDC 0087-6063-13. Recall # D-337-3.
CODE
Lot No. Exp. date 304622 Jan 2005 304623 Mar 2005 304624 Mar 2005 305518 Mar 2005 305519 Mar 2005 305520 Mar 2005 305521 Mar 2005 305522 Mar 2005 305523 Mar 2005 305524 Mar 2005 305525 Mar 2005 305526 Mar 2005 305527 Mar 2005 305528 Mar 2005 305529 Mar 2005 305530 Mar 2005 305531 Mar 2005 305532 Mar 2005 305535 Mar 2005.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letter on August 13, 2003. Firm initiated recall is ongoing.
REASON
Subpotency; some tablets may contain less than the minimum specification for potency (blend validation).
VOLUME OF PRODUCT IN COMMERCE
205,655 units.
DISTRIBUTION
Nationwide.
PRODUCT
Glucophage XR tablets (metformin HCl extended release), 500 mg, 100 count bottles, Rx only, Distributed by: Bristol-Myers Squibb Company, Princeton, NJ, NDC 0087-6063-13. Recall # D-337-3.
CODE
Lot No. Exp. date 304622 Jan 2005 304623 Mar 2005 304624 Mar 2005 305518 Mar 2005 305519 Mar 2005 305520 Mar 2005 305521 Mar 2005 305522 Mar 2005 305523 Mar 2005 305524 Mar 2005 305525 Mar 2005 305526 Mar 2005 305527 Mar 2005 305528 Mar 2005 305529 Mar 2005 305530 Mar 2005 305531 Mar 2005 305532 Mar 2005 305535 Mar 2005.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letter on August 13, 2003. Firm initiated recall is ongoing.
REASON
Subpotency; some tablets may contain less than the minimum specification for potency (blend validation).
VOLUME OF PRODUCT IN COMMERCE
205,655 units.
DISTRIBUTION
Nationwide.
