PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: October 17, 2012 Initiated: August 14, 2012 #D-005-2013

Product Description

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.

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
14,868 Bottles
Distribution
Nationwide & Puerto Rico
Location
Lincolnton, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Actavis Mid Atlantic LLC. Units affected: 14,868 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-005-2013.