Product Detail

Product Description Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

Recall Number D-542-2013

Classification Class II

Code Info Lot# 11EQ008 Exp 04/13; Lot# 11HQ003 Exp. 07/13; Lot# 12JQ007 Exp. 08/14.

Product Distributed Qty 40,149 - 30 mL 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