Drug product
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
D-0554-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0554-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lots: 10029307 Exp. 11/14/2019, 10029939 Exp. 11/20/2019, 10029884 Exp. 11/19/2019, 10029915 Exp. 11/20/2019, 10030385 Exp. 11/25/2019, 10030386 Exp. 11/25/2019, 10030923 Exp. 12/11/2019, 10031320 Exp. 12/11/2019, 10031025 Exp. 12/12/2019, 10031024 Exp. 12/12/2019, 10032678 Exp. 1/8/2020, 10032993 Exp. 1/14/2020
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter