Reported Jun 12, 2013 · Terminated
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals…
TG United, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TG United, Inc. · 16275 Aviation Loop Dr · Brooksville, FL · 34604-6805
Is this the product you have?
- ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC
- Manufactured forEdwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 Lot# 11L008 Exp. 10/13 2 Lot# 12A001 Exp. 12/13 3 Lot# 12A002 Exp. 12/13 4 Lot# 12A006 Exp. 12/13 5 Lot#12A006 Exp. 12/13 6 Lot# 12A007 Exp. 12/13 7 Lot#12D013 Exp. 03/14 8 Lot# 12F002 Exp. 05/14 9 Lot# 12H006 Exp.07/14 10 Lot# 12J001 Exp. 08/14 11 Lot# 12J001 Exp. 08/14 12 Lot# 12K005 Exp. 09/14 13 Lot #12M002 Exp. 11/14 14 Lot# 12M003 Exp. 11/14. - Amount recalled
- 242,470
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new TG United, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.