Recalls / Class II
Class IID-0099-2017
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.
- Affected lot / code info
- a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
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
- 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
- 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-0099-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.