FDA Drug recall D-0548-2020
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 W…
- FDA Drug
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 W… 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-0548-2020 |
| 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 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10030056…Lots: 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10030056 Exp. 11/24/2019, 10029883 Exp. 11/19/2019, 10030867 Exp. 11/27/2019, 10030056 Exp. 11/24/2019, 10031005 Exp. 12/4/2019, 10030950 Exp. 12/3/2019, 10031005 Exp. 12/4/2019, 10031103 Exp. 12/6/2019, 10031006 Exp. 12/4/2019, 10031142 Exp. 12/8/2019, 10031274 Exp. 12/10/2019, 10031710 Exp. 12/12/2019, 10031628 Exp. 12/19/2019, 10031777 Exp. 12/22/2019, 10031683 Exp. 12/22/2019, 10032050 Exp. 12/29/2019, 10032051 Exp. 12/29/2019, 10032435 Exp. 1/2/2020, 10032468 Exp. 1/2/2020, 10032545 Exp. 1/5/2020, 10032676 Exp. 1/8/2020, 10032677 Exp. 1/8/2020, 10032595 Exp. 1/6/2020, 10032545 Exp. 1/5/2020, 10032596 Exp. 1/6/2020 |
|---|
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-0548-2020%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.