Home / Recalls / QuVa Pharma, Inc. / D-0297-2025

D-0297-2025 Class II Ongoing

Recalled by QuVa Pharma, Inc. — Sugar Land, TX

Recall Details

Product Type
Drugs
Report Date
April 2, 2025
Initiation Date
March 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,765 cassettes

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S. Nationwide

Code Information

Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025

Other recalls by QuVa Pharma, Inc.

  • D-0113-2026 Class II — R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamin (October 10, 2025)
  • D-0295-2025 Class II — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 m (March 6, 2025)
  • D-0296-2025 Class II — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 (March 6, 2025)
  • D-1544-2022 Class III — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injectio (September 20, 2022)
  • D-1302-2020 Class II — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection (May 28, 2020)
  • D-1335-2020 Class III — R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride sol (April 23, 2020)
  • D-0552-2020 Class II — fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) (November 12, 2019)
  • D-0566-2020 Class II — fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx (November 12, 2019)
  • D-0547-2020 Class II — fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 (November 12, 2019)
  • D-0569-2020 Class II — fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharm (November 12, 2019)