fentaNYL 500 mcg/250 mL — Class II drug recall D-0547-2020
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-0547-2020 |
|---|---|
| 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 | 70092-1105-37 |
| Lot numbers | 10029289, 10029841, 10029861, 10029863, 10029946, 10030008, 10030009, 10030010, 10030430, 10030482, 10030483, 10030907, 10030908, 10030958, 10030959, 10030989, 10031283, 10031345, 10031346, 10031433, 10031434, 10031477, 10031478, 10031479, 10031568, 10031569, 10031570, 10031591, 10031615, 10031642, 10031759, 10031760, 10031813, 10031814, 10031845, 10031846, 10031946, 10031975, 10031976, 10031977 and 12 more |
| Expiration dates | 2019-11-14, 2019-11-19, 2019-11-21, 2019-11-24, 2019-11-26, 2019-11-27, 2019-12-02, 2019-12-03, 2019-12-04, 2019-12-11, 2019-12-12, 2019-12-15, 2019-12-16, 2019-12-18, 2019-12-19, 2019-12-20, 2019-12-23, 2019-12-24, 2019-12-26, 2019-12-27, 2019-12-29, 2019-12-30, 2019-12-31, 2020-01-01, 2020-01-02 and 2 more |
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
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-0547-2020. 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.