FDAHealthMarch 6, 2025
QuVa Pharma, Inc. — 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), Co
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 6, 2025
U.S. Nationwide
What's affected?
- Product
- 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
- Brand
- QuVa Pharma, Inc.
- Lot code
- 10140259
Additional details
Lots: 10140259, 10140539, 10140687, 10140688; Exp 04/24/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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