fentaNYL 1000 mcg/100 mL — Class II drug recall D-0555-2020
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-0555-2020 |
|---|---|
| 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 | 70092-1092-36 |
| Lot numbers | 10029286, 10029287, 10029754, 10029761, 10029764, 10029787, 10029862, 10029892, 10029893, 10029947, 10029951, 10030011, 10030012, 10030018, 10030345, 10030346, 10030424, 10030425, 10030880, 10030881, 10030882, 10030933, 10030934, 10030935, 10030982, 10030983, 10030984, 10030985, 10031035, 10031036, 10031037, 10031038, 10031174, 10031175, 10031198, 10031199, 10031232, 10031233, 10031242, 10031386 and 48 more |
| Expiration dates | 2019-11-14, 2019-11-17, 2019-11-18, 2019-11-20, 2019-11-21, 2019-11-24, 2019-11-26, 2019-12-02, 2019-12-03, 2019-12-04, 2019-12-05, 2019-12-09, 2019-12-10, 2019-12-15, 2019-12-16, 2019-12-19, 2019-12-20, 2019-12-24, 2019-12-26, 2019-12-27, 2019-12-29, 2019-12-30, 2019-12-31, 2020-01-05, 2020-01-06 and 2 more |
Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
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-0555-2020. 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.