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.
Reported: March 21, 2018 Initiated: March 5, 2018 #D-0586-2018
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 205,370 vials
- Distribution
- Nationwide in the USA.
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sagent Pharmaceuticals Inc. Units affected: 205,370 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 21, 2018. Severity: Moderate. Recall number: D-0586-2018.
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