Drug 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
D-0331-2015
Product summary
- Event
- Event 70168
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 3936 bottles; b) 84420 bottles
- Official record key
drug-enforcement:D-0331-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification