notyard
10-08-2009, 09:17 AM
FDA class III recall:
PRODUCT
Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100 tablets per bottle, Rx only, NDC 53746-0203-01. Recall # D-1976-2009
CODE
The subject bottle was shipped together with the identical product Lot # BC00609, Exp 02/11
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Brookhaven, NY, by letter dated June 23, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect/Missing Lot No. (s): One bottle of Oxycodone and Acetaminophen 5 mg/325 mg tablets, 100 count bottle was found without a lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE
6,931 bottles
DISTRIBUTION
Nationwide
PRODUCT
Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100 tablets per bottle, Rx only, NDC 53746-0203-01. Recall # D-1976-2009
CODE
The subject bottle was shipped together with the identical product Lot # BC00609, Exp 02/11
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Brookhaven, NY, by letter dated June 23, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect/Missing Lot No. (s): One bottle of Oxycodone and Acetaminophen 5 mg/325 mg tablets, 100 count bottle was found without a lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE
6,931 bottles
DISTRIBUTION
Nationwide