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PRODUCT
Aspirin and Codeine Phosphate Tablets, USP, 325 mg/60 mg,
100 count bottles, Rx only. Recall # D-120-4.

CODE
Lot Number 101304A/Expiration Date: 3/2004.

RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami, FL, by letter on November 11, 2003. Firm initiated recall is ongoing.

REASON
Stability Failure: Product is exceeding the stability specification for free Salicylic Acid.

VOLUME OF PRODUCT IN COMMERCE
4,392 bottles.

DISTRIBUTION
Nationwide.