Drug product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
D-0551-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0551-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lots: 10029934 Exp. 11/19/2019, 10029820 Exp. 11/18/2019, 10029872 Exp. 11/19/2019, 10029873 Exp. 11/19/2019, 10030868 Exp. 11/28/2019, 10030567 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10030567 Exp. 11/28/2019, 10030568 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10031210 Exp. 12/9/2019, 10031211 Exp. 12/9/2019, 10031209 Exp. 12/12/2019, 10031439 Exp. 12/15/2019, 10031700 Exp. 12/22/2019, 10031438 Exp. 12/15/2019, 10031766 Exp. 12/26/2019, 10032225 Exp.12/29/2019, 10032260 Exp. 12/30/2019, 10032343 Exp. 12/31/2019,
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter