RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II ___________________________________
PRODUCT
Carbamazepine (Chewable) Tablets USP, 100mg, 100 tablets (10x10) unit dose blister packs, Recall # D-238-2008 CODE Lot # 073553, Exp. Date 7/31/2009 RECALLING FIRM/MANUFACTURER Recalling Firm: American Health Packaging, Columbus, OH, by letters on April 1, 2008.
Manufacturer: Taro Pharmaceuticals Industries U.S.A., Inc., Haifa Bay, Israel. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification: 6 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE
1,078/100mg tablet blister packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III ___________________________________
PRODUCT
Menopur (menotropins for injection, USP), 75 IU, carton containing: 5 single-dose vials of Menotropins for Injection, 5 single-dose vials of 0.9% Sodium Chloride Injection, and 5 Q-Cap Vial Adapters, Rx only. Outer carton NDC 55566-7501-2, Recalling # D-240-2008 CODE
Lots: CB0613A-1, exp. 5/09 and CB0613A-2, exp 5/09 RECALLING FIRM/MANUFACTURER Recalling Firm: Ferring Pharmaceuticals, Inc., Parsippany, NJ, by letters on May 30, 2008.
Manufacturer: Ferring GmbH, Kiel, Germany. Firm initiated recall is ongoing.
REASON
Outer carton label contains a misprint of active ingredients. Label lists 75 IU of FSH twice when it should read 75 IU of FSH and 75 IU of LH.
VOLUME OF PRODUCT IN COMMERCE
15,955 cartons
DISTRIBUTION
Nationwide


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