Reported Jun 12, 2013 · Terminated
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC…
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 PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02
- Manufactured forPernix Therapeutics, Gonzales, LA 70737
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot# 11AQ004 Exp. 12/12 2 Lot# 11AQ005 Exp. 12/12 3 Lot # 11AQ006 Exp. 12/12 4 Lot# 11AQ007 Exp. 12/12 5 Lot # 11BQ012 Exp. 01/13 6 Lot# 11LQ003 Exp. 10/13 7 Lot# 11LQ004 Exp. 10/13 8 Lot# 11LQ005 Exp 10/13 9 Lot# 11LQ006 Exp. 10/2013. - Amount recalled
- 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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