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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 Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
Recall Number D-521-2013
Classification Class II
Code Info Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.
Product Distributed Qty 216,838 bottles - 30 mL
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