Drug product
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
D-0560-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0560-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lots: 10030458 Exp. 11/26/2019, 10031113 Exp. 12/5/2019, 10031305 Exp. 12/11/2019, 10031417 Exp. 12/15/2019, 10031765 Exp. 12/26/2019, 10032259 Exp. 12/30/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter