FDA recall D-0296-2025

QuVa Pharma, Inc. · Class II · drug

Product

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-06
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2025