FDA-Drug2013-06-12Class II
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, 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
19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-527-2013Don't want to check this manually?
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