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
Reason for recall: Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Recall initiated: 20120814
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated