FDA Drug recall D-0551-2020
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Lan…
- FDA Drug
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Lan… 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-0551-2020 |
| 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 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Identifiers
| code_info | Lots: 10029934 Exp. 11/19/2019, 10029820 Exp. 11/18/2019, 10029872 Exp. 11/19/2019, 10029873 Exp. 11/19/2019,…Lots: 10029934 Exp. 11/19/2019, 10029820 Exp. 11/18/2019, 10029872 Exp. 11/19/2019, 10029873 Exp. 11/19/2019, 10030868 Exp. 11/28/2019, 10030567 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10030567 Exp. 11/28/2019, 10030568 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10031210 Exp. 12/9/2019, 10031211 Exp. 12/9/2019, 10031209 Exp. 12/12/2019, 10031439 Exp. 12/15/2019, 10031700 Exp. 12/22/2019, 10031438 Exp. 12/15/2019, 10031766 Exp. 12/26/2019, 10032225 Exp.12/29/2019, 10032260 Exp. 12/30/2019, 10032343 Exp. 12/31/2019, |
|---|
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-0551-2020%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.