notyard
04-14-2009, 12:43 PM
FDA class II recall:
PRODUCT
Propranolol Hydrochloride Extended Release Capsules, USP, 120 mg, 100 Capsules; NDC 0228-2780-11; Rx only, Recall # D-173-2009
CODE
Lot: 071A81, Exp. 12/2009
RECALLING FIRM/MANUFACTURER
Actavis Elizabeth LLC, Elizabeth, NJ, by letters on December 15, 2008. Firm initiated recall is ongoing.
REASON
Potency; failed stability specification for fill weight of capsules (too much or too little active).
VOLUME OF PRODUCT IN COMMERCE
7,434 bottles
DISTRIBUTION
Nationwide
PRODUCT
Propranolol Hydrochloride Extended Release Capsules, USP, 120 mg, 100 Capsules; NDC 0228-2780-11; Rx only, Recall # D-173-2009
CODE
Lot: 071A81, Exp. 12/2009
RECALLING FIRM/MANUFACTURER
Actavis Elizabeth LLC, Elizabeth, NJ, by letters on December 15, 2008. Firm initiated recall is ongoing.
REASON
Potency; failed stability specification for fill weight of capsules (too much or too little active).
VOLUME OF PRODUCT IN COMMERCE
7,434 bottles
DISTRIBUTION
Nationwide