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
Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Recall initiated: 20141222
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated