TG United, Inc. recalls AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AM
Recalled June 12, 2013 · FDA recall D-512-2013 · TG United
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime. · FDA Class II
Units
1772 bottles per 100 count each
Sold at
FL, MS, SC, LA and TX
Description
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
Manufacturer(s)
TG United, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →