Product Detail

Product Description BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

Recall Number D-524-2013

Classification Class II

Code Info Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.

Product Distributed Qty 10,036 bottles - 100-count tablets

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