Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Recalled March 21, 2018 · FDA recall D-0587-2018 · Sagent Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: High out of specification results for an impurity. · FDA Class II
Units
176,410 vials
Sold at
Nationwide in the USA.
Description
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Product
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.
Manufacturer(s)
Sagent Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →