Home / Recalls / TG United, Inc. / D-529-2013

D-529-2013 Class II Terminated

Recalled by TG United, Inc. — Brooksville, FL

Recall Details

Product Type
Drugs
Report Date
June 12, 2013
Initiation Date
January 30, 2013
Termination Date
September 30, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
330158 Bulk tablets.

Product Description

Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

Reason for Recall

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

Distribution Pattern

FL, MS, SC, LA and TX

Code Information

Lot# 12L005 Exp 10/14.

Other recalls by TG United, Inc.

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  • D-516-2013 Class II — NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distri (January 30, 2013)
  • D-520-2013 Class II — Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactur (January 30, 2013)
  • D-531-2013 Class II — Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bo (January 30, 2013)
  • D-517-2013 Class II — Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manu (January 30, 2013)
  • D-536-2013 Class II — Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, M (January 30, 2013)
  • D-543-2013 Class II — Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bo (January 30, 2013)
  • D-507-2013 Class II — AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, (January 30, 2013)
  • D-523-2013 Class II — Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured (January 30, 2013)
  • D-534-2013 Class II — CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bot (January 30, 2013)