AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04

Recall Number: D-503-2013

Firm: TG United, Inc.

Classification: Class II

Status: Terminated

Report Date: 20130612

Initiation Date: 20130130

Termination Date: 20160930

Reason for Recall

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

Product Description

AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04

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Data source: openFDA · Updated regularly