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

AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry…

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 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16

Recalling firm
TG United, Inc.
NDC code
66870-0223-16
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-506-2013

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.