FDAClass IIMay 22, 2024

MethylPREDNISolone Acetate Injectable Suspension recall: Particulate Matter

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT…

Why was MethylPREDNISolone Acetate Injectable Suspension recalled?

Presence of Particulate Matter: Potential for black particulates in the drug product.

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 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025

Product
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT…
Recalling firm
Sagent Pharmaceuticals
Quantity
14,360 vials
Distribution
Nationwide in the USA
Recall date
May 22, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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