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3/26/04 at 4:20pm
Thread Starter 
PRODUCT
Butalbital, Aspirin & Caffeine Tablets,USP,
50mg-Butalbital/325mg-Aspirin/40mg-Caffeine, CIII,
100 count bottles, Rx only. Recall # D-116-4.

CODE
Lot Number/Expiration Date: 539C21, 04/2004;
541C21, 04/2004; 743D21, 05/2004; 744D21, 05/2004;
745D21, 05/2004; 746D21, 05/2004; 281F21, 07/2004;
284F21, 07/2004; 285F21, 08/2004.

RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on January 13, 2004. FDA initiated recall is ongoing.

REASON
Stability Failure: Product lacks stability for Butalbital drug ingredient.

VOLUME OF PRODUCT IN COMMERCE
96,113.

DISTRIBUTION
Nationwide.
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