notyard
04-15-2009, 08:55 AM
FDA class II recall:
PRODUCT
Bellaspas Tablets, Phenobarbital USP, 40mg; Ergotamine Tartrate USP, 0.6mg; Levorotary alkaloids of belladonna 0.2mg; 100 and 500 count, Rx only, Recall # D-208-2009
CODE
Lot numbers: T020A06A, exp. 11/08; T020A06B, exp. 11/08; T076D06A, exp. 11/08; and T076D06B, exp 11/08
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville AL, by letters on September 15, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; 18month Stability
VOLUME OF PRODUCT IN COMMERCE
16,416 units
DISTRIBUTION
Nationwide
PRODUCT
Bellaspas Tablets, Phenobarbital USP, 40mg; Ergotamine Tartrate USP, 0.6mg; Levorotary alkaloids of belladonna 0.2mg; 100 and 500 count, Rx only, Recall # D-208-2009
CODE
Lot numbers: T020A06A, exp. 11/08; T020A06B, exp. 11/08; T076D06A, exp. 11/08; and T076D06B, exp 11/08
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville AL, by letters on September 15, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; 18month Stability
VOLUME OF PRODUCT IN COMMERCE
16,416 units
DISTRIBUTION
Nationwide