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

Agency Publication Date: October 9, 2012

Affected Products

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.

X111001, X111008, X111030, Exp 10/13

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

X110042, X110051, X110064, Exp 09/13

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62827

Status: Resolved

Manufacturer: Actavis Mid Atlantic LLC

Manufactured In: United States

Units Affected: 2 products (14,868 Bottles; 19,980 Bottles)

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Sources: FDA iRES · Raw API Response

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