TG United, Inc. recalls BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02,
Recalled June 12, 2013 · FDA recall D-526-2013 · TG United
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime. · FDA Class II
Units
57,936 bottles - 20 mL and 7,476 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 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
Manufacturer(s)
TG United, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →