PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 12, 2013 Initiated: January 30, 2013 #D-527-2013

Product Description

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.

Details

Recalling Firm
TG United, Inc.
Units Affected
19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Distribution
FL, MS, SC, LA and TX
Location
Brooksville, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by TG United, Inc.. Units affected: 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce..
Why was this product recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-527-2013.