FDA recall D-0113-2026

QuVa Pharma, Inc. · Class II · drug

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 for recall

Presence of Particulate Matter

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-10-10
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0113-2026