FDA Drug Recalls

Recalls / Class II

Class IID-1064-2016

Product

Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612

Affected lot / code info
Lot #: a) 84172, b) 84173, 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
17802 units
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-1064-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls