Recalls / Class II

Class IID-1065-2016

Product

Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159

Affected lot / code info

Lot #: 84126, Exp FEB/2017

Why it was recalled

Failed Content Uniformity Specifications.

Recalling firm

Firm

Allergan Sales, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

8301 Mars Dr, N/A, Waco, Texas 76712-6578

Distribution

Quantity

N/A

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2016-05-10

FDA classified

2016-07-06

Posted by FDA

2016-07-13

Terminated

2017-12-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1065-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.