Home / Recalls / Actavis Mid Atlantic LLC / D-005-2013

D-005-2013 Class III Terminated

Recalled by Actavis Mid Atlantic LLC — Lincolnton, NC

Recall Details

Product Type: Drugs
Report Date: October 17, 2012
Initiation Date: August 14, 2012
Termination Date: June 27, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,868 Bottles

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.

Distribution Pattern

Nationwide & Puerto Rico

Code Information

X111001, X111008, X111030, Exp 10/13