FDA Drug recall D-0561-2020
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 bag, Preservative Free, Rx…
- 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 bag, Preservative Free, Rx… 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-0561-2020 |
| 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 bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029…Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029977 Exp. 11/20/2019 10029978 Exp. 11/21/2019 10029979 Exp. 11/21/2019 10030041 Exp. 11/21/2019 10030043 Exp. 11/21/2019 10030396 Exp. 11/25/2019 10030960 Exp. 12/2/2019 10030961 Exp. 12/4/2019 10030962 Exp. 12/4/2019 10031010 Exp. 12/4/2019 10031011 Exp. 12/4/2019 10031012 Exp. 12/4/2019 10030960 Exp. 12/2/2019 10031086 Exp. 12/6/2019 10030960 Exp. 12/2/2019 10031263 Exp. 12/10/2019 10031262 Exp. 12/10/2019 10031413 Exp. 12/15/2019 10031463 Exp. 12/16/2019 10031696 Exp. 12/22/2019 10031947 Exp. 12/26/2019 10031948 Exp. 12/31/2019 10032414 Exp. 1/2/2020 10031978 Exp. 1/1/2020 10031948 Exp. 12/31/2019 10032412 Exp. 1/2/2020 10032413 Exp. 1/2/2020 10032687 Exp. 1/8/2020 10032723 Exp. 1/9/2020 10033037 Exp. 1/23/2020 10032929 Exp. 1/26/2020 |
|---|
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-0561-2020%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.