Reported Jun 12, 2013 · Terminated
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for:…
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?
- AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC
- Manufactured forAMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
- Lot codes and dates
Lot # 11D001 Exp. 03/13Lot # 11D002 Exp. 03/13Lot#11K003 Exp. 09/13Lot# 12C010 Exp. 02/14
- Amount recalled
- 1772 bottles per 100 count each
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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