FDA Drug recall D-0546-2020
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 10…
- 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 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 10… 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-0546-2020 |
| 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 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019,…Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, , 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, , 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, , 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019,, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019,, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/ |
|---|
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-0546-2020%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.