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…
QuVa Pharma, Inc. · Lack of Assurance of Sterility
- Status
- Ongoing
- City
- Sugar Land
- State
- TX
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96446
- Recalling firm
- QuVa Pharma, Inc.
- Address 1
- 1075 W Park One Dr Ste 100
- Address 2
- N/A
- Postal code
- 77478-2576
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
- Recall number
- D-0296-2025
- Product quantity
- 2,310 cassettes
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20250306
- Center classification date
- 20250325
- Report date
- 20250402
- 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
- Product description
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