Drug product
fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
D-0572-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0572-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lot: 10031855 Exp. 12/24/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter