Product Detail

Product Description TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

Recall Number D-538-2013

Classification Class II

Code Info Lot# 11CQ011 Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008 Exp. 03/13; Lot# 11EQ002 Exp. 04/13; Lot # 11KQ004 Exp 09/13; Lot# 11KQ005 Exp. 09/13

Product Distributed Qty 98,202 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