FDA recall D-540-2013

Product

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

Reason for recall

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

Distribution

FL, MS, SC, LA and TX

Key facts

Status

Terminated

Initiation date

2013-01-30

Report date

2013-06-12

Termination date

2016-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-540-2013