FDA Drug recall D-0549-2020
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharm…
- 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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharm… 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-0549-2020 |
| 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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 100…Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020 |
|---|
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-0549-2020%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.