FDA-Drug2013-06-12Class II

BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

TG United, Inc.
Hazard

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Sold states
FL, MS, SC, LA and TX
Affected count
57,936 bottles - 20 mL and 7,476 bottles -16 ounce
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-526-2013

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