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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 ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
Recall Number D-545-2013
Classification Class II
Code Info Lot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.
Product Distributed Qty 39,801 - 30 mL bottles.
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