RecallWatchUSA

Home / Recalls / Drugs

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, NDC

Recalled January 14, 2015 · FDA recall D-0331-2015 · Qualitest Pharmaceuticals

Hazard
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. · FDA Class III
Units
a) 3936 bottles; b) 84420 bottles
Sold at
Nationwide

Description

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

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
Manufacturer(s)
Qualitest Pharmaceuticals

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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, NDC | RecallWatchUSA