US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 30, 2013 (14 years ago)

AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
TG United, Inc.
NDC code
66870-0200-04
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-503-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.