Recalls / Class II
Class IID-0499-2024
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 Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
- Brand name
- Methylprednisolone Acetate
- Generic name
- Methylprednisolone Acetate
- Active ingredient
- Methylprednisolone Acetate
- Route
- Intra-articular, Intralesional, Intramuscular, Intrasynovial, Soft Tissue
- NDCs
- 25021-820, 25021-821
- FDA application
- ANDA201835
- Affected lot / code info
- Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Why it was recalled
Presence of Particulate Matter: Potential for black particulates in the drug product.
Recalling firm
- Firm
- Sagent Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, N/A, Schaumburg, Illinois 60195
Distribution
- Quantity
- 14,360 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-04-25
- FDA classified
- 2024-05-15
- Posted by FDA
- 2024-05-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0499-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.