TG United, Inc. recalls BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02
Recalled June 12, 2013 · FDA recall D-527-2013 · TG United
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime. · FDA Class II
Units
19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Sold at
FL, MS, SC, LA and TX
Description
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product
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
Manufacturer(s)
TG United, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →