Product: Prometh VC Plain, Each 5mL contains: 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 0472-1628-16.
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