fentaNYL 500 mcg/250 mL — Class II drug recall D-0546-2020
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-0546-2020 |
|---|---|
| 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 | 70092-1160-37 |
| Lot numbers | 10029199, 10029297, 10029737, 10029763, 10029785, 10029789, 10029790, 10029894, 10029950, 10030006, 10030007, 10030336, 10030431, 10030432, 10030453, 10030454, 10030886, 10030887, 10030909, 10030941, 10030942, 10030990, 10030991, 10031056, 10031057, 10031058, 10031087, 10031088, 10031152, 10031153, 10031178, 10031179, 10031236, 10031237, 10031376, 10031616, 10031617, 10031731, 10031732, 10031950 and 19 more |
| Expiration dates | 2019-11-14, 2019-11-17, 2019-11-18, 2019-11-20, 2019-11-21, 2019-11-24, 2019-11-26, 2019-11-27, 2019-12-02, 2019-12-03, 2019-12-04, 2019-12-05, 2019-12-06, 2019-12-08, 2019-12-09, 2019-12-10, 2019-12-19, 2019-12-22, 2019-12-26, 2019-12-29, 2019-12-30, 2019-12-31, 2020-01-02, 2020-01-05, 2020-01-06 and 3 more |
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
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-0546-2020. 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.