Why it was recalled
Lack of Assurance of Sterility
Product description
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 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: 70092-1259-75
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0297-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 6, 2025
- FDA report date
- Apr 2, 2025
- Quantity
- 1,765 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0297-2025, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 96446
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
- Postal code
- 77478-2576
- Report date
- Apr 2, 2025
- Product type
- Drugs
- Recall number
- D-0297-2025
- Classification
- Class II
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 1,765 cassettes
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 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: 70092-1259-75
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Mar 6, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2025