FDA recall D-527-2013

TG United, Inc. · Class II · drug

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

Reason for recall

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

Distribution

FL, MS, SC, LA and TX

Key facts

Status: Terminated
Initiation date: 2013-01-30
Report date: 2013-06-12
Termination date: 2016-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-527-2013