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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 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
Recall Number D-006-2013
Classification Class III
Code Info X110042, X110051, X110064, Exp 09/13
Product Distributed Qty 19,980 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