Sagent Pharmaceuticals recalls 400mg/10mL MethylPREDNISolone Acetate Injectable Suspension vials due to potential black particulates. Affected lots manufactured in India, expiring Jan 2025. Stop using immediately.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals is recalling a specific injectable steroid medication vial because it may contain black particles. This could cause serious injury if injected. The recall affects vials with specific lot numbers made in India.
Black particles in the injectable medication could cause serious injury or death when administered. Particulate matter in injectable drugs is a known hazard as it may clog blood vessels or cause tissue damage.
Prescription patients using the recalled vial for steroid treatment. Those with the specific lot numbers (5100186-5100189) manufactured in India are most at risk.
Check for vials labeled 'MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial'. Look for lot numbers 5100186 through 5100189 made in India, expiring January 2025.
Discard the vial if you have the recalled lot numbers (5100186-5100189) manufactured in India.
The recall is due to potential black particulates in the drug product that could cause serious injury if injected.
Lot numbers 5100186, 5100187, 5100188, and 5100189.
Made in India by Sagent Pharmaceuticals.
Check for vials labeled 'MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial' with lot numbers 5100186-5100189.
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0499-2024 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-0499-2024 from Sagent Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
