QuVa Pharma, Inc.: Drug Recall

Recall #D-0295-2025 · 03/06/2025

Class II: Risk

Recall Details

Recall Number: D-0295-2025
Classification: Class II
Product Type: Drug
Recalling Firm: QuVa Pharma, Inc.
Status: Ongoing
Date Initiated: 03/06/2025
Location: Sugar Land, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

U.S. Nationwide

Other Recalls by QuVa Pharma, Inc.

Class II: Risk 10/10/2025

Presence of Particulate Matter
Class II: Risk 03/06/2025

Lack of Assurance of Sterility
Class II: Risk 03/06/2025

Lack of Assurance of Sterility
Class III: Low Risk 09/20/2022

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

View all recalls by QuVa Pharma, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.