FDA-Drug2013-06-12Class II
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
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
12,198 - 16 ounce bottles.
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-540-2013Don't want to check this manually?
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