drugs Class III Updated 2012-10-17

Actavis Mid Atlantic LLC recalls Prometh VC Plain, Each 5mL contains: Promethazine Hydrochlor

Recalled 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.

Hazard / Issue

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: X111001, X111008, X111030, Exp 10/13
View official government recall

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