methylPREDNISolone Sodium Succinate for Injection recall: Impurity Out of Spec
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL…
Why was methylPREDNISolone Sodium Succinate for Injection recalled?
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AJM601, Exp. Jul-2018; AJM701, AJM702, Exp. Dec-2018
- Product
- methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL…
- Recalling firm
- Sagent Pharmaceuticals Inc
- Quantity
- 205,370 vials
- Distribution
- Nationwide in the USA.
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)