notyard
08-06-2008, 06:08 PM
FDA Class III recall:
PRODUCT
Acetaminophen and Codeine Phosphate O r a l Solution USP, Each 5mL (one teaspoonful) contains: Acetaminophen 120 mg and Codeine phosphate 12 mg, in 4 fl oz bottles (NDC 0472-1419-04) and 16 fl oz bottles (NDC 0472-1419-16), Rx Only, Recall # D-279-2008
CODE
Lot: Q02055, expiration date 07/2009
RECALLING FIRM/MANUFACTURER
Actavis Mid-Atlantic, LLC, Baltimore, MD, by letter on April 30, 2008. Firm initiated recall is ongoing.
REASON
Degradation; acetaminophen (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
41,975 bottles
DISTRIBUTION
Nationwide
PRODUCT
Acetaminophen and Codeine Phosphate O r a l Solution USP, Each 5mL (one teaspoonful) contains: Acetaminophen 120 mg and Codeine phosphate 12 mg, in 4 fl oz bottles (NDC 0472-1419-04) and 16 fl oz bottles (NDC 0472-1419-16), Rx Only, Recall # D-279-2008
CODE
Lot: Q02055, expiration date 07/2009
RECALLING FIRM/MANUFACTURER
Actavis Mid-Atlantic, LLC, Baltimore, MD, by letter on April 30, 2008. Firm initiated recall is ongoing.
REASON
Degradation; acetaminophen (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
41,975 bottles
DISTRIBUTION
Nationwide