Reported Jun 12, 2013 · Terminated
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02,…
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 LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02
- Manufactured forPernix Therapeutics, Gonzales, LA 70737
- Lot codes and dates
Lot# 11CQ005 Exp. 02/13Lot# 11LQ002 Exp. 10/13Lot # 12CQ005-Exp. 02/14Lot# 12EQ003 Exp. 04/14Lot# 12EQ004 Exp. 04/14Lot# 12JQ004 Exp. 08/14
- Amount recalled
- 57,936 bottles - 20 mL and 7,476 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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