R — Class III drug recall D-1335-2020
Terminated recall by QuVa Pharma, Inc., reported 2020-07-01, distributed nationwide. Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
| Recall number | D-1335-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QuVa Pharma, Inc., Sugar Land, TX, United States |
| Recall initiated | 2020-04-23 |
| Classified | 2020-06-23 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2021-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 17,050 syringes |
| Reason classes | specification failure |
| Lot numbers | 30008198, 30008554, 30008721, 30008859, 30008861, 30008949, 30009073, 30009074, 30009138, 30009139, 30009227, 30009228, 30009387, 30009388, 30009410, 30009411, 30009412, 30009413, 30009489, 30009539, 30009563 |
| Expiration dates | 2020-04-26, 2020-04-29, 2020-04-30, 2020-05-05, 2020-05-10, 2020-05-14, 2020-05-17, 2020-05-19, 2020-05-20, 2020-05-27, 2020-05-28, 2020-05-31, 2020-06-01, 2020-06-03 |
Product
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
Reason for recall
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
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-1335-2020. 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.