Drug Enforcement D-524-2013

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

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

September 30, 2016

Product Information

Product description
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Product quantity
10,036 bottles - 100-count tablets
Reason for recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
FL, MS, SC, LA and TX

Location & Firm

Recalling firm
TG United, Inc.
Address
16275 Aviation Loop Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-524-2013
Event ID
64188
Recall initiation date
January 30, 2013
Center classification date
June 4, 2013
Code info
Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.
More code info
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