FDA-Drug2013-06-12Class II

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

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
355 - 16 ounce bottles
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-509-2013

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