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Recall Observatory FDA recall evidence

Drug product

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

D-0295-2025

March 06, 2025

Class II

Product summary

Firm
QuVa Pharma, Inc.
Event
Event 96446
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0295-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 10140259, 10140539, 10140687, 10140688; Exp 04/24/2025

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility