TG United, Inc. recalls AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured
Recalled June 12, 2013 · FDA recall D-504-2013 · TG United
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime. · FDA Class II
Units
348 - 16 ounce bottles.
Sold at
FL, MS, SC, LA and TX
Description
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
Manufacturer(s)
TG United, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →