FDA recall D-0099-2017

Allergan Sales, LLC · Class II · drug

Product

TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.

Reason for recall

Failed Content Uniformity Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-06-30
Report date: 2016-10-19
Termination date: 2017-12-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waco, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2017