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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 ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
Recall Number D-515-2013
Classification Class II
Code Info Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.
Product Distributed Qty 242,470
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
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