Product Detail

Product Description TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

Recall Number D-537-2013

Classification Class II

Code Info Lot# 11AQ003 Exp 12/12.

Product Distributed Qty 2532 - 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