Reported Mar 21, 2018 · Terminated
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent…
Sagent Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sagent Pharmaceuticals Inc · 1901 N Roselle Rd Ste 700 · Schaumburg, IL · 60195-3194
Is this the product you have?
- methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd
- forSagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10
- Lot codes and dates
Lot #: AJN601Exp. Jun-2018AJN701AJN702Exp. Dec-2018
- Amount recalled
- 176,410 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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