Qualitest Pharmaceuticals recalls ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, ND…

Recall date

December 22, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0331-2015

FDA classification

Class III

Brand / firm

Qualitest Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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