Recalls / Class II
Class IID-0100-2017
Product
TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
- Affected lot / code info
- Lot # 85037; Exp 05/17 Lot # 82583; Exp 10/16
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
- 17,112 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-30
- FDA classified
- 2016-10-13
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0100-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.