FDA-Drug2013-06-12Class II

Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

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
39,403 - 30 mL bottles
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-541-2013

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