drugs Class II Updated 2013-06-12

TG United, Inc. recalls BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl

Recalled 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


Hazard / Issue

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

Issued by

FDA

Affected States: FL, MS, SC, LA, TX
Lot/Code Info: Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013.
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