FDA-Drug2013-06-12Class II

ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

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
39,801 - 30 mL bottles.
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-545-2013

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