Drug Enforcement D-530-2013

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
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
Product quantity
977,719 Bulk 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-530-2013
Event ID
64188
Recall initiation date
January 30, 2013
Center classification date
June 4, 2013
Code info
Lot# 11F005 Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003 Exp 08/12.
More code info
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