PRODUCT
Darvon Compound USP 32 (Propoxyphene hydrochloride 32 mg,
aspirin 389 mg and caffeine 32.4 mg), 100 Pulvules, Rx
only. Recall # D-111-4.
CODE
Lot Numbers: Lot 03082B, 03083B and 03084B.
RECALLING FIRM/MANUFACTURER
Aaipharma, Wilmington, NC, by email on January 8, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Aspirin and Propoxphene hydrochloride (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,328 bottles.
DISTRIBUTION
Nationwide.
Darvon Compound USP 32 (Propoxyphene hydrochloride 32 mg,
aspirin 389 mg and caffeine 32.4 mg), 100 Pulvules, Rx
only. Recall # D-111-4.
CODE
Lot Numbers: Lot 03082B, 03083B and 03084B.
RECALLING FIRM/MANUFACTURER
Aaipharma, Wilmington, NC, by email on January 8, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Aspirin and Propoxphene hydrochloride (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,328 bottles.
DISTRIBUTION
Nationwide.




