Reported May 22, 2024 · Ongoing

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

Sagent Pharmaceuticals

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sagent Pharmaceuticals · 1901 N Roselle Rd Ste 450 · Schaumburg, IL · 60195

Is this the product you have?

  • 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 Pharmaceuticals, Schaumburg, IL 60195, Made in India
  • NDC25021-820-10
Lot codes and dates
    • Lots 5100186
    • 5100187
    • 5100188
    • 5100189
    • Exp 01/31/2025
Amount recalled
14,360 vials

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:55 PM UTC

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