Class II
Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 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
This recall is currently active, issued April 2, 2025. It was issued by Quva Pharma, Inc..
- Company
- Quva Pharma, Inc.
- Recall Initiated
- March 6, 2025
- Posted
- April 2, 2025
- Recall Number
- D-0295-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Sugar Land, TX, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide
Lot / Code Info
Lots: 10140259, 10140539, 10140687, 10140688; Exp 04/24/2025
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