Class II
Ongoing
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
- Company
- Sagent Pharmaceuticals
- Recall Initiated
- April 25, 2024
- Posted
- May 22, 2024
- Recall Number
- D-0499-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,360 vials
- Firm Location
- Schaumburg, IL, United States
Reason for Recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Distribution
Nationwide in the USA
Lot / Code Info
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
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