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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 BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
Recall Number D-525-2013
Classification Class II
Code Info Lot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.
Product Distributed Qty 16,836 bottles - 100-count.
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