FDA Drug recall D-0113-2026
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe
- FDA Drug
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe by Quva Pharma, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0113-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Quva Pharma |
| Distribution | US |
Product
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
Reason
Presence of Particulate Matter
Identifiers
| code_info | Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/1…Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/16/2025 ; 10149658 , exp 10/16/2025 ; 10149659 , exp 10/15/2025 ; 10150137 , exp 10/23/2025 ; 10150138 , exp 10/23/2025 ; 10150139 , exp 10/23/2025 ; 10150140 , exp 10/23/2025 ; 10149729 , exp 10/16/2025 ; 10149730 , exp 10/16/2025 ; 10149732 , exp 10/16/2025 ; 10149733 , exp 10/16/2025 ; 10149737 , exp 10/16/2025 ; 10149738 , exp 10/16/2025 ; 10149790 , exp 10/17/2025 ; 10149787 , exp 10/16/2025 ; 10149788 , exp 10/16/2025 ; 10149791 , exp 10/17/2025 ; 10149792 , exp 10/16/2025 ; 10149800 , exp 10/16/2025 ; 10149841 , exp 10/19/2025 ; 10149833 , exp 10/19/2025 ; 10149840 , exp 10/19/2025 ; 10149842 , exp 10/20/2025 ; 10149838 , exp 10/19/2025 ; 10149839 , exp 10/19/2025 ; 10149843 , exp 10/20/2025 ; 10149968 , exp 10/20/2025 ; 10149969 , exp 10/21/2025 ; 10150007 , exp 10/22/2025 ; 10150134 , exp 10/23/2025 ; 10150253 , exp 10/26/2025 ; 1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0113-2026%22
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