Actavis Mid Atlantic LLC recalls Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottl
Recalled October 17, 2012 · FDA recall D-005-2013 · Actavis Mid Atlantic
Hazard
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. · FDA Class III
Units
14,868 Bottles
Sold at
Nationwide & Puerto Rico
Description
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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.
Manufacturer(s)
Actavis Mid Atlantic LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →