FDAClass IIJune 12, 2013

TL Hist DM recall: CGMP Deviations

TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC…

Why was TL Hist DM recalled?

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC…
Recalling firm
TG United, Inc.
Quantity
98,202 16 ounce bottles.
Distribution
FL, MS, SC, LA and TX
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls