FDAFDA · Food and drugs·Recall number D-0499-2024
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. NDC: 25021-820-10
Published May 22, 2024 · Recall initiated: April 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Potential for black particulates in the drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METHYLPREDNISOLONE ACETATE
- Manufacturer
- Sagent Pharmaceuticals
- Distributor
- Nationwide in the USA
- Lot
- Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.