The Recall Desk
ModerateFDA (Drugs)·D-535-2013·Announced 2013-06-12

TG United Recalls Mesehist DM Due to CGMP Deviations

TG United, Inc. is recalling Mesehist DM cough and cold medicine because the product is underdosed or has an incorrect dosage regime.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a CGMP deviation involving incorrect dosage without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

TG United, Inc. is voluntarily recalling 12,120 16-ounce bottles of Mesehist DM, an over-the-counter antihistamine, antitussive, and decongestant. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the product being underdosed or having an incorrect dosage regime.

The affected product is manufactured for Trigen Laboratories and is identified by NDC 13811-0085-16. The specific lots subject to the recall are 11CQ010 (Exp 02/13), 11EQ003 (Exp 04/13), 11FQ002 (Exp 05/13), 11FQ003 (Exp 05/13), and 12HQ009 (Exp 07/14). These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.

Consumers who have purchased this product should check their bottles for the lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
Manufacturer
TG United, Inc.
Category
Drug — Over-the-Counter Cough and Cold Medicine
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 (5)

  • Lot# 11CQ010 Exp 02/13
  • Lot# 11EQ003 Exp. 04/13
  • Lot# 11FQ002 Exp. 05/13
  • Lot# 11FQ003 Exp. 05/13
  • Lot# 12HQ009 Exp. 07/14.

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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