fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL),...
FDA Recall #D-0296-2025 — Class II — March 6, 2025
Product Description
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
Recalling Firm
QuVa Pharma, Inc. — Sugar Land, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,310 cassettes
Distribution
U.S. Nationwide
Code Information
Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated