fentaNYL 200 mcg/100 mL — Class II drug recall D-0548-2020
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-0548-2020 |
|---|---|
| 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 | 70092-1259-75 |
| Lot numbers | 10029829, 10029883, 10030056, 10030867, 10030950, 10031005, 10031006, 10031103, 10031142, 10031274, 10031628, 10031683, 10031710, 10031777, 10032050, 10032051, 10032435, 10032468, 10032545, 10032595, 10032596, 10032676, 10032677 |
| Expiration dates | 2019-11-18, 2019-11-19, 2019-11-24, 2019-11-27, 2019-12-03, 2019-12-04, 2019-12-06, 2019-12-08, 2019-12-10, 2019-12-12, 2019-12-19, 2019-12-22, 2019-12-29, 2020-01-02, 2020-01-05, 2020-01-06, 2020-01-08 |
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
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-0548-2020. 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.