drugs Class III Updated 2015-01-14

Qualitest Pharmaceuticals recalls ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 m

Recalled Product

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Hazard / Issue

Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15
View official government recall

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