fentaNYL 1250 mcg/250 mL — Class II drug recall D-0567-2020
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-0567-2020 |
|---|---|
| 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 | 70092-1444-05 |
| Lot numbers | 10029186, 10029791, 10030403, 10030456, 10030910, 10031130, 10031154, 10031182, 10031238, 10031482, 10031483, 10031592, 10031621, 10031869, 10031898, 10031921, 10032219, 10032369, 10032393, 10032561, 10032586 |
| Expiration dates | 2019-11-18, 2019-11-25, 2019-11-27, 2019-12-02, 2019-12-08, 2019-12-09, 2019-12-10, 2019-12-16, 2019-12-19, 2019-12-24, 2019-12-25, 2019-12-26, 2019-12-29, 2020-01-01, 2020-01-06 |
Product
fentaNYL 1250 mcg/250 mL (5 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 70092-1444-05
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-0567-2020. 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.