Home / Recalls / TG United, Inc. / D-512-2013

D-512-2013 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
1772 bottles per 100 count each

Product Description

AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01

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 # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.

Other recalls by TG United, Inc.

  • D-503-2013 Class II — AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flav (January 30, 2013)
  • 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)