FDA Drug recall D-0547-2020
fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma…
- 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) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma… 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-0547-2020 |
| 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) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019,…Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27 |
|---|
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-0547-2020%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.