FDA Drug recall D-0560-2020
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747…
- FDA Drug
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747… by Quva Pharma, citing presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0560-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-12 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Quva Pharma |
| Distribution | US |
Product
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10030458 Exp. 11/26/2019, 10031113 Exp. 12/5/2019, 10031305 Exp. 12/11/2019, 10031417 Exp. 12/15/2019,…Lots: 10030458 Exp. 11/26/2019, 10031113 Exp. 12/5/2019, 10031305 Exp. 12/11/2019, 10031417 Exp. 12/15/2019, 10031765 Exp. 12/26/2019, 10032259 Exp. 12/30/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0560-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.