D-0565-2020 Class II Terminated
FDA drug recall D-0565-2020 was initiated by QuVa Pharma, Inc. on November 12, 2019 and is designated Class II. Reason for recall: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules The recall status is terminated (terminated June 5, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2019
- Initiation Date
- November 12, 2019
- Termination Date
- June 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
Code Information
Lots: 10029200 Exp. 11/18/2019, 10030347 Exp. 11/24/2019, 10031325 Exp. 12/16/2019, 10030939 Exp. 12/3/2019, 10031865 Exp. 12/24/2019, 10031758 Exp. 12/26/2019, 10031757 Exp. 12/26/2019, 10032275 Exp. 12/30/2019