PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 19, 2016 Initiated: June 30, 2016 #D-0099-2017

Product Description

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

Details

Recalling Firm
Allergan Sales, LLC
Units Affected
25,247 tubes (19,499 30 gram/ 5,748 100 gram)
Distribution
Nationwide
Location
Waco, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Allergan Sales, LLC. Units affected: 25,247 tubes (19,499 30 gram/ 5,748 100 gram).
Why was this product recalled?
Failed Content Uniformity Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on October 19, 2016. Severity: Moderate. Recall number: D-0099-2017.