The Recall Desk
SevereFDA (Drugs)·D-540-2013·Announced 2013-06-12

TG United Recalls Tri-Dex PE Due to Underdosing and Dosage Errors

TG United, Inc. is recalling 12,198 bottles of Tri-Dex PE because the product is underdosed or has an incorrect dosage regime.

What this means for you

Illness, injury, or structural failure has been reported. 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, as the dosage errors could lead to serious temporary or medically reversible health consequences.

Plain-English summary

TG United, Inc. is recalling 12,198 16-ounce bottles of Tri-Dex PE, an over-the-counter antihistamine, antitussive, and nasal decongestant. The recall was initiated because the products are underdosed or have an incorrect dosage regime, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product is manufactured for Trigen Laboratories in Sayreville, NJ, and carries NDC 13811-088-16. The recall covers specific lots with expiration dates ranging from May 2013 to July 2014. These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
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 (5)

  • 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.

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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