FDA recall D-0587-2018

Product

methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-03-21

Termination date

2020-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0587-2018