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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

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.
Recall Number D-005-2013
Classification Class III
Code Info X111001, X111008, X111030, Exp 10/13
Product Distributed Qty 14,868 Bottles
Reason For Recall Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

Event Detail

Event Id 62827
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Mid Atlantic LLC
City Lincolnton
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide & Puerto Rico