WhichRecall
Class IIReported 2025-04-02

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

Recalled by QuVa Pharma, Inc.

Reason for Recall

Lack of Assurance of Sterility

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Recall Number
D-0297-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-03-06
Reported
2025-04-02
Distribution
U.S. Nationwide
Code Info
Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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