Drug product
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
D-0563-2020
Product summary
- Event
- Event 84263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0563-2020
Official wording
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Code information: Lots: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter