Recalls / Class II
Class IID-0296-2025
Product
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
- Affected lot / code info
- Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 2,310 cassettes
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-06
- FDA classified
- 2025-03-25
- Posted by FDA
- 2025-04-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0296-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.