FDA-Drug2024-05-22Class II
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
Sagent Pharmaceuticals
Hazard
Presence of Particulate Matter: Potential for black particulates in the drug product.
Sold states
Nationwide in the USA
Affected count
14,360 vials
Manufactured in
1901 N Roselle Rd Ste 450, N/A, Schaumburg, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0499-2024Don't want to check this manually?
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