• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

  • Print
  • Share
  • E-mail

Product Detail

Product Description Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
Recall Number D-535-2013
Classification Class II
Code Info Lot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002 Exp. 05/13; Lot# 11FQ003 Exp. 05/13; Lot# 12HQ009 Exp. 07/14.
Product Distributed Qty 12,120 - 16 ounce 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