FDA-Drug2013-06-12Class II
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
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
1398 - 4 ounce bottles
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-503-2013Don't want to check this manually?
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