FDA Drug recall D-0559-2020
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD 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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD 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-0559-2020 |
| 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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 1…Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10030949 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10031377 Exp. 12/6/2019, 10031141 Exp. 12/9/2019, 10031423 Exp. 12/15/2019, 10031627 Exp. 12/19/2019, 10031709 Exp. 12/22/2019, 10031907 Exp. 12/25/2019, 10032022 Exp. 12/27/2019, 10031858 Exp. 12/24/2019, 10032381 Exp. 1/1/2020, 10032296 Exp. 12/31/2019, 10032268 Exp. 12/30/2019, 10032467 Exp. 1/2/2020, 10032674 Exp. 1/8/2020, 10032569 Exp. 1/6/2020, 10032570 Exp. 1/6/2020, 10032516 Exp. 1/5/2020, 10032517 Exp. 1/5/2020, 10032674 Exp. 1/8/2020, 10032570 Exp. 1/6/2020, 10032675 Exp. 1/8/2020, 10033019 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.
Other recalls by Quva Pharma
- Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Su…
FDA Drug · Class II · 2026-07-15 · Quva Pharma - R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe
FDA Drug · Class II · 2025-11-05 · Quva Pharma - fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection…
FDA Drug · Class II · 2025-04-02 · Quva Pharma - fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for E…
FDA Drug · Class II · 2025-04-02 · Quva Pharma - fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for E…
FDA Drug · Class II · 2025-04-02 · Quva Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0559-2020%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.