Drug 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.
D-0099-2017
Product summary
- Event
- Event 74623
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
- Official record key
drug-enforcement:D-0099-2017
Official wording
Reason: Failed Content Uniformity Specifications
Code information: a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications