FDA-Drug2013-06-12Class II
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
TG United, Inc.
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Sold states
FL, MS, SC, LA and TX
Affected count
1772 bottles per 100 count each
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-512-2013Don't want to check this manually?
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