Product Detail

Product Description Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

Recall Number D-540-2013

Classification Class II

Code Info Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.

Product Distributed Qty 12,198 - 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