fentaNYL 200 mcg/100 mL — Class II drug recall D-0557-2020
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-0557-2020 |
|---|---|
| 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 | 70092-1202-75 |
| Lot numbers | 10029306, 10029748, 10029854, 10029881, 10029882, 10030442, 10030894, 10030947, 10031295, 10031319, 10031468, 10031518, 10031553, 10031582, 10031775, 10031802, 10031882, 10031906, 10031960, 10032021, 10032380, 10032405, 10032543, 10032594, 10032673, 10032703 |
| Expiration dates | 2019-11-14, 2019-11-17, 2019-11-18, 2019-11-19, 2019-11-26, 2019-12-02, 2019-12-03, 2019-12-11, 2019-12-16, 2019-12-17, 2019-12-18, 2019-12-22, 2019-12-23, 2019-12-24, 2019-12-25, 2019-12-26, 2019-12-27, 2020-01-01, 2020-01-05, 2020-01-06, 2020-01-08 |
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
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-0557-2020. 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.