Sagent Pharmaceuticals recalls MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx on
Recalled May 22, 2024 · FDA recall D-0499-2024 · Sagent Pharmaceuticals
Hazard
Presence of Particulate Matter: Potential for black particulates in the drug product. · FDA Class II
Units
14,360 vials
Sold at
Nationwide in the USA
Description
Presence of Particulate Matter: Potential for black particulates in the drug product.
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
Manufacturer(s)
Sagent Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →