FDA Drug Class III — Least Serious

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

Hazard

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

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Products

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
Brand
Actavis Mid Atlantic LLC
UPC
X110042, X110051, X110064, Exp 09/13

Units Affected

19,980 Bottles

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