FDA Recall D-1059-2019
Mylan Institutional Inc · Rockford, IL
Class I — life-threatening Terminated 504 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
Reason for recall
Presence of Particulate Matter: particulate matter identified as copper salts
Recall record
- Recall number
D-1059-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the United States
- Recall initiated
- 2019-02-01
- Classified by FDA Center
- 2019-03-26
- FDA published
- 2019-03-20
- Terminated
- 2020-06-19
- Recalling firm
- Mylan Institutional Inc
- Firm location
- Rockford, IL