Reported Jun 12, 2013 · Terminated
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix…
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?
- BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC
- Manufactured forPernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
- Lot codes and dates
Lot# 11A002 Exp. 12/12Lot# 11A003 Exp. 12/12Lot # 11A004 Exp. 12/12Lot# 11A005 Exp. 12/12Lot# 11L003 Exp. 10/13
- Amount recalled
- 16,836 bottles - 100-count.
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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