PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 17, 2012 Initiated: August 14, 2012 #D-006-2013

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Actavis Mid Atlantic LLC
Units Affected
19,980 Bottles
Distribution
Nationwide & Puerto Rico
Location
Lincolnton, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Actavis Mid Atlantic LLC. Units affected: 19,980 Bottles.
Why was this product recalled?
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 17, 2012. Severity: Low. Recall number: D-006-2013.