fentaNYL 500 mcg/250 mL — Class II drug recall D-0549-2020
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-0549-2020 |
|---|---|
| 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 | 70092-1269-37 |
| Lot numbers | 10029288, 10029762, 10029788, 10029838, 10029948, 10029949, 10030337, 10030455, 10030539, 10030888, 10030943, 10030963, 10030964, 10031129, 10031284, 10031414, 10031435, 10031735, 10032253, 10032280, 10032535, 10032585, 10033009 |
| Expiration dates | 2019-11-14, 2019-11-18, 2019-11-19, 2019-11-21, 2019-11-24, 2019-11-26, 2019-11-28, 2019-12-02, 2019-12-03, 2019-12-08, 2019-12-11, 2019-12-15, 2019-12-16, 2019-12-22, 2019-12-30, 2019-12-31, 2020-01-06, 2020-01-14, 2020-01-15 |
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
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-0549-2020. 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.