fentaNYL 400 mcg/200 mL — Class II drug recall D-0562-2020
Terminated recall by QuVa Pharma, Inc., reported 2019-12-11, distributed nationwide. Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
| Recall number | D-0562-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QuVa Pharma, Inc., Sugar Land, TX, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 70092-1207-37 |
| Lot numbers | 10029343, 10029344, 10029345, 10029895, 10029918, 10029919, 10030398, 10030399, 10030400, 10031059, 10031060, 10031061, 10031089, 10031326, 10031327, 10031328, 10031480, 10031504, 10031505, 10031506, 10031507, 10031618, 10031619, 10031672, 10031733, 10031734, 10031791, 10031792, 10031793, 10031815, 10031816, 10031817, 10031847, 10031897, 10031919, 10032251, 10032252, 10032278, 10032279, 10032334 and 9 more |
| Expiration dates | 2019-11-15, 2019-11-20, 2019-11-25, 2019-12-05, 2019-12-06, 2019-12-12, 2019-12-17, 2019-12-18, 2019-12-19, 2019-12-20, 2019-12-22, 2019-12-23, 2019-12-24, 2019-12-25, 2019-12-30, 2019-12-31, 2020-01-01, 2020-01-06, 2020-01-07, 2020-01-12, 2020-01-13, 2020-01-16 |
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
Reason for recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0562-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.