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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 (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
Recall Number D-299-2013
Classification Class II
Code Info Lot #: 11611B0, Batch # 114039, Exp 10/14
Product Distributed Qty 11,580 cartons
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