drugs Class II Updated 2013-06-12

TG United, Inc. recalls AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nas

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: FL, MS, SC, LA, TX
Lot/Code Info: Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.
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