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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
Recall Number D-522-2013
Classification Class II
Code Info Lot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.
Product Distributed Qty 2706 bottles of 100 count tablets
Reason For Recall CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Event Detail

Event Id 64188
Product Type Drugs
Status Ongoing
Recalling Firm TG United, Inc.
City Brooksville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern FL, MS, SC, LA and TX