fentaNYL 200 mcg/100 mL — Class II drug recall D-0559-2020
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-0559-2020 |
|---|---|
| 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 | 70092-1255-75 |
| Lot numbers | 10029914, 10030342, 10030895, 10030948, 10030949, 10031141, 10031377, 10031423, 10031627, 10031709, 10031858, 10031907, 10032022, 10032268, 10032296, 10032381, 10032467, 10032516, 10032517, 10032569, 10032570, 10032674, 10032675, 10033019 |
| Expiration dates | 2019-11-20, 2019-11-24, 2019-12-02, 2019-12-03, 2019-12-06, 2019-12-09, 2019-12-15, 2019-12-19, 2019-12-22, 2019-12-24, 2019-12-25, 2019-12-27, 2019-12-30, 2019-12-31, 2020-01-01, 2020-01-02, 2020-01-05, 2020-01-06, 2020-01-08, 2020-01-15 |
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 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-0559-2020. 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.