drugs Class II Updated 2013-06-12

TG United, Inc. recalls Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant,

Recalled Product

Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

Hazard / Issue

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Issued by

FDA

Affected States: FL, MS, SC, LA, TX
Lot/Code Info: Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.
View official government recall

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