FDAFDA · Food and drugs·Recall number D-0586-2018
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
Published March 21, 2018 · Recall initiated: March 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Sagent Pharmaceuticals Inc
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: AJM601, Exp. Jul-2018; AJM701, AJM702, Exp. Dec-2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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