Home / Recalls / TG United, Inc. / D-509-2013

D-509-2013 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
355 - 16 ounce bottles

Product Description

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

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 # 12DQ004, Exp. 03/14.

Other recalls by TG United, Inc.

  • D-513-2013 Class II — AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceutical (January 30, 2013)
  • D-521-2013 Class II — Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC (January 30, 2013)
  • D-534-2013 Class II — CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bot (January 30, 2013)
  • D-535-2013 Class II — Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, M (January 30, 2013)
  • 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-540-2013 Class II — Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OT (January 30, 2013)