Actavis Mid Atlantic LLC recalls Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; p
Recalled October 17, 2012 · FDA recall D-006-2013 · Actavis Mid Atlantic
Hazard
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. · FDA Class III
Units
19,980 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 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
Manufacturer(s)
Actavis Mid Atlantic LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →