RecallDepth
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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