Drug 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.
D-0100-2017
Product summary
- Event
- Event 74623
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,112 tubes
- Official record key
drug-enforcement:D-0100-2017
Official wording
Reason: Failed Content Uniformity Specifications
Code information: Lot # 85037; Exp 05/17 Lot # 82583; Exp 10/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications