Product Detail

Product Description 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

Recall Number D-526-2013

Classification Class II

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.

Product Distributed Qty 57,936 bottles - 20 mL and 7,476 bottles -16 ounce

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

Event Detail

Event Id 64188

Product Type Drugs

Status Ongoing

Recalling Firm
TG United, Inc.
City Brooksville
State FL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-01-30

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern FL, MS, SC, LA and TX