QuVa Pharma, Inc. recalls R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounde…
- Recall date
- April 23, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1335-2020
- FDA classification
- Class III
- Brand / firm
- QuVa Pharma, Inc.
- Sold / distributed
- Distributed Nationwide in the US.
Why it was recalled
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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