notyard
08-22-2009, 01:03 PM
FDA class II recall:
PRODUCT
1) Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 100 Bags of One Tablet Each, Rx only, (ETHEX NDC) NDC 58177-222-11, D-1885-2009;
2) Potassium Chloride Extended-release Capsules, USP, 10 mEq (750 mg), 100 Bags of One Capsule Each, Rx only, NDC 58177-001-11 (ETHEX NDC), Recall # D-1886-2009
CODE
1) Lot # 084610, Exp 06/12; Lot # 084741, Exp 06/12; Lot # 080846, Exp 07/11; Lot # 081324, Exp 07/11; Lot # 074739, Exp 03/11; Lot # 075164, Exp 03/11; Lot # 072945, Exp 01/11; Lot # 073432, Exp 01/11; Lot # 071711, Exp 10/10; Lot # 071116, Exp 10/10; Lot # 066048, Exp 06/10; Lot # 066443, Exp 06/10; Lot # 068039, Exp 06/10; Lot # 070004, Exp 06/10;
2) Lot # 080851, Exp 08/10; Lot # 074872, Exp 03/10; Lot # 073305, Exp 12/09; Lot # 072004, Exp 11/09; Lot # 071053, Exp 10/09; Lot # 068333, Exp 07/09; Lot # 066983, Exp 04/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on February 2, 2009 and February 5, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with cGMP’s.
VOLUME OF PRODUCT IN COMMERCE
924 units (100 tablets per unit)
DISTRIBUTION
Nationwide
PRODUCT
1) Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 100 Bags of One Tablet Each, Rx only, (ETHEX NDC) NDC 58177-222-11, D-1885-2009;
2) Potassium Chloride Extended-release Capsules, USP, 10 mEq (750 mg), 100 Bags of One Capsule Each, Rx only, NDC 58177-001-11 (ETHEX NDC), Recall # D-1886-2009
CODE
1) Lot # 084610, Exp 06/12; Lot # 084741, Exp 06/12; Lot # 080846, Exp 07/11; Lot # 081324, Exp 07/11; Lot # 074739, Exp 03/11; Lot # 075164, Exp 03/11; Lot # 072945, Exp 01/11; Lot # 073432, Exp 01/11; Lot # 071711, Exp 10/10; Lot # 071116, Exp 10/10; Lot # 066048, Exp 06/10; Lot # 066443, Exp 06/10; Lot # 068039, Exp 06/10; Lot # 070004, Exp 06/10;
2) Lot # 080851, Exp 08/10; Lot # 074872, Exp 03/10; Lot # 073305, Exp 12/09; Lot # 072004, Exp 11/09; Lot # 071053, Exp 10/09; Lot # 068333, Exp 07/09; Lot # 066983, Exp 04/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on February 2, 2009 and February 5, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with cGMP’s.
VOLUME OF PRODUCT IN COMMERCE
924 units (100 tablets per unit)
DISTRIBUTION
Nationwide