FDAClass IIApril 2, 2025

fentaNYL Citrate PF 200 mcg/100 mL recall: Sterility Concern

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…

Why was fentaNYL Citrate PF 200 mcg/100 mL recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
QuVa Pharma, Inc.
Quantity
N/A
Distribution
U.S. Nationwide
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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