FDAFDA · Food and drugs·Recall number D-0297-2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 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: 70092-1259-75
Published April 2, 2025 · Recall initiated: March 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- QuVa Pharma, Inc.
- Distributor
- U.S. Nationwide
- Lot
- Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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