Reported Jun 12, 2013 · Terminated
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen…
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?
- TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC
- Manufactured forTrigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
- Lot codes and dates
Lot# 11CQ011 Exp 02/13Lot# 11DQ007 Exp. 03/13Lot# 11DQ008 Exp. 03/13Lot# 11EQ002 Exp. 04/13Lot # 11KQ004 Exp 09/13Lot# 11KQ005 Exp. 09/13
- Amount recalled
- 98,202 16 ounce bottles.
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.
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