FDA-Drug2018-03-21Class II
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
Sagent Pharmaceuticals Inc
Hazard
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Sold states
Nationwide in the USA.
Affected count
176,410 vials
Manufactured in
1901 N Roselle Rd Ste 700, Schaumburg, IL, United States
Products
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0587-2018Don't want to check this manually?
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