← FDA ENFORCEMENT
D-0499-2024Class II

Sagent Pharmaceuticals

Recalling firm
Sagent Pharmaceuticals
Product type
Drug
Status
Ongoing
Report date
2024-05-22
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
14,360 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter: Potential for black particulates in the drug product.

Product description

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

Code / lot info

Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.