Drug product
fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
D-0566-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0566-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lots: 10030359 Exp. 11/21/2019, 10030549 Exp. 11/28/2019, 10031169 Exp. 12/8/2019, 10031491 Exp. 12/16/2019, 10031879 Exp. 12/24/2019, 10032317 Exp. 12/31/2019, 10032265 Exp. 12/30/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter