drugs Class II Updated 2013-06-12

TG United, Inc. recalls BroveX PSE DM, Antihistamine, Cough Suppressant, Decongest

Recalled Product

BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

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# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.
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