Recall
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
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.

View original FDA notice →

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