FDA Drug recall D-0552-2020
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, R…
- FDA Drug
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, R… 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-0552-2020 |
| 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 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019,…Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 10031092 12/6/2019, 10031349 Exp. 12/12/2019, 10032011 Exp. 12/27/2019, 10032012 Exp. 12/27/2019, 10032505 Exp. 1/5/2020, 10032447 Exp. 1/2/2020, 10032932 Exp. 1/13/2020, |
|---|
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-0552-2020%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.