AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

Recall Number: D-508-2013

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 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.