FDA recall D-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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-04-25

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0499-2024