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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. X111001, X111008, X111030, Exp 10/13 Class III Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. 14,868 Bottles D-005-2013
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 X110042, X110051, X110064, Exp 09/13 Class III Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. 19,980 Bottles D-006-2013
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