The Recall Desk
SevereFDA (Drugs)·D-517-2013·Announced 2013-06-12

TG United Recalls Dallergy Tablets Due to Underdosing and Dosage Errors

TG United, Inc. is recalling Dallergy tablets because they are underdosed or have an incorrect dosage regime. The recall affects specific lots distributed in five states.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported, the 'underdosed' nature of a pharmaceutical product poses a significant risk of treatment failure or adverse effects, aligning with the Severe criteria for significant risk.

Plain-English summary

TG United, Inc. is recalling Dallergy TABLETS, an over-the-counter antihistamine and nasal decongestant, due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the products are underdosed or have an incorrect dosage regime.

The recall involves 31,739 bottles of 100-count tablets and 842,617 bulk tablet bottles. The affected lots include 11L006, 12B003, 12D005, and 12H001, with expiration dates ranging from October 2013 to July 2014. 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 the manufacturer or their healthcare provider for guidance. The FDA has classified this recall as Class II.

The recalled product

Product
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
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 (7)

  • Lot# 11L006 Exp. 10/13
  • Lot# 11L006 Exp. 10/13
  • Lot# 12B003 Exp 01/14
  • Lot# 12B003 Exp. 01/14
  • Lot#12D005 Exp. 03/14
  • Lot# 12D005 Exp. 03/14
  • Lot# 12H001 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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