The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-538-2013·Announced 2013-06-12

TG United Recalls TL Hist DM Due to Underdosing

TG United, Inc. is recalling TL Hist DM antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential harm or incorrect dosage regimes.

Plain-English summary

TG United, Inc. is voluntarily recalling 98,202 bottles of TL Hist DM, an over-the-counter antihistamine, decongestant, and cough suppressant. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the products are underdosed or have an incorrect dosage regime.

The affected product is the 16 fl oz. bottle, manufactured for Trigen Laboratories. The recall covers specific lots with expiration dates ranging from February 2013 to September 2013. These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.

Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
Manufacturer
TG United, Inc.
Category
Drug — Over-the-Counter Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 44 products in this recall →

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