drugs Class II Updated 2013-06-12

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

Recalled 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


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# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14.
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