Multi event Drug Recall Enforcement Report Class II voluntary initiated by Allergan Sales, LLC, originally initiated on 06-30-2016 for the 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. The product was recalled due to failed content uniformity specifications. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0099-2017 | 06-30-2016 | 10-19-2016 | Class II | 25,247 tubes (19,499 30 gram/ 5,748 100 gram) | 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. | Failed Content Uniformity Specifications | Terminated |
| D-0100-2017 | 06-30-2016 | 10-19-2016 | Class II | 17,112 tubes | 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. | Failed Content Uniformity Specifications | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0023-0042 | Tazorac | Tazarotene | Gel | Cutaneous | Allergan, Inc. | Human Prescription Drug |
| 0023-8335 | Tazorac | Tazarotene | Gel | Cutaneous | Allergan, Inc. | Human Prescription Drug |
