Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent P…
- Recall date
- March 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0588-2018
- FDA classification
- Class II
- Brand / firm
- Sagent Pharmaceuticals Inc
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
Get recall alerts
Free email alert whenever Sagent Pharmaceuticals Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Sagent Pharmaceuticals Inc