Drug product
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
D-006-2013
Product summary
- Event
- Event 62827
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19,980 Bottles
- Official record key
drug-enforcement:D-006-2013
Official wording
Reason: Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Code information: X110042, X110051, X110064, Exp 09/13
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Unknown
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.