AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16

Recall Number: D-507-2013

Firm: TG United, Inc.

Classification: Class II

Status: Terminated

Report Date: 20130612

Initiation Date: 20130130

Termination Date: 20160930

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

AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16