April 2024 FDA Recall Methylprednisolone Acetate by Sagent Pharmaceuticals
D-0499-2024 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals on April 25, 2024 for the product Methylprednisolone Acetate. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0499-2024
Presence of Particulate Matter: Potential for black particulates in the drug product.
04-25-2024
05-22-2024
14,360 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sagent Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
