Home / Recalls / TG United, Inc. / D-515-2013

D-515-2013 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
242,470

Product Description

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

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# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.

Other recalls by TG United, Inc.

  • 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-507-2013 Class II — AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, (January 30, 2013)
  • D-539-2013 Class II — TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufa (January 30, 2013)
  • D-537-2013 Class II — TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, (January 30, 2013)
  • D-525-2013 Class II — BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottl (January 30, 2013)
  • D-534-2013 Class II — CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bot (January 30, 2013)