Recalls / Class II
Class IID-0588-2018
Product
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.
- Affected lot / code info
- Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 48,964 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-03-05
- FDA classified
- 2018-03-12
- Posted by FDA
- 2018-03-21
- Terminated
- 2020-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0588-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.