ED A-HIST Tablets (TG United) – Dosage Incorrect (2013)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
Brand
TG United, Inc.
Lot Codes / Batch Numbers
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# 12J001 Exp. 08/14, Lot# 12K005 Exp. 09/14, Lot #12M002 Exp. 11/14, Lot# 12M003 Exp. 11/14.
Products Sold
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# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.
TG United, Inc. is recalling ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwa due to CGMP Deviations: Products are underdosed or have an incorrect dosage regime.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, LA, MS, SC, TX
Page updated: Jan 7, 2026