TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
Recall Number: D-537-2013
Firm: TG United, Inc.
Classification: Class II
Status: Terminated
Report Date: 20130612
Initiation Date: 20130130
Termination Date: 20160930
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Description
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16