fentaNYL 2500 mcg/250 mL — Class II drug recall D-0553-2020
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-0553-2020 |
|---|---|
| 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 | 70092-1093-37 |
| Lot numbers | 10029202, 10029753, 10029756, 10029757, 10029758, 10029792, 10029793, 10029808, 10029809, 10029810, 10029897, 10029920, 10030394, 10030395, 10030426, 10030427, 10030448, 10030449, 10030450, 10030451, 10030479, 10030480, 10030481, 10030506, 10030507, 10030508, 10030883, 10030884, 10030885, 10030902, 10030903, 10030904, 10030936, 10030937, 10030938, 10030955, 10030956, 10030957, 10030986, 10030987 and 57 more |
| Expiration dates | 2019-11-17, 2019-11-18, 2019-11-19, 2019-11-20, 2019-11-25, 2019-11-26, 2019-11-27, 2019-11-30, 2019-12-02, 2019-12-03, 2019-12-04, 2019-12-08, 2019-12-09, 2019-12-10, 2019-12-11, 2019-12-16, 2019-12-17, 2019-12-18, 2019-12-19, 2019-12-20, 2019-12-22, 2019-12-23, 2019-12-24, 2019-12-25, 2019-12-29 and 5 more |
Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
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-0553-2020. 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.