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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
Recall Number D-300-2013
Classification Class II
Code Info Lot #: 11649A0, Exp 12/13
Product Distributed Qty 7,610 bottles
Reason For Recall Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Event Detail

Event Id 64933
Product Type Drugs
Status Ongoing
Recalling Firm OPMX, LLC
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide