D-0556-2020 Class II Terminated
FDA drug recall D-0556-2020 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 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
Code Information
Lots: 10029772 Exp. 11/17/2019, 10030627 Exp. 11/22/2019, 10030626 Exp. 11/21/2019, 10030408 Exp. 11/25/2019, 10030512 Exp. 11/27/2019, 10030408 Exp. 11/25/2019, 10031107 Exp. 12/5/2019, 10031268 Exp. 12/10/2019, 10031437 Exp. 12/15/2019, 10031821 Exp. 12/23/2019, 10032285 Exp. 12/30/2019