The Recall Desk
SevereFDA (Drugs)·D-515-2013·Announced 2013-06-12

TG United Recalls ED A-Hist Tablets Due to Underdosing

TG United, Inc. is recalling ED A-Hist Tablets because they are underdosed or have 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 rating under the rubric for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

TG United, Inc. is recalling ED A-Hist Tablets, an over-the-counter antihistamine and nasal decongestant product. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.

The affected product is manufactured for Edwards Pharmaceuticals Inc. and is sold in 100-count bottles. The recall covers approximately 242,470 units distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers who have purchased these products should stop using them and return them to the point of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
Manufacturer
TG United, Inc.
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
242,470

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 (13)

  • Lot# 11L008 Exp. 10/13
  • Lot# 12A001 Exp. 12/13
  • Lot# 12A002 Exp. 12/13
  • Lot# 12A006 Exp. 12/13
  • Lot#12A006 Exp. 12/13
  • Lot# 12A007 Exp. 12/13
  • Lot#12D013 Exp. 03/14
  • Lot# 12F002 Exp. 05/14
  • Lot# 12H006 Exp.07/14
  • Lot# 12J001 Exp. 08/14
  • Lot# 12K005 Exp. 09/14
  • Lot #12M002 Exp. 11/14
  • Lot# 12M003 Exp. 11/14.

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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