FDA Recall D-1333-2015
Mylan Institutional LLC · Rockford, IL
Class I — life-threatening Terminated 424 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
Reason for recall
Presence of Particulate Matter
Recall record
- Recall number
D-1333-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2015-03-23
- Classified by FDA Center
- 2015-08-14
- FDA published
- 2015-08-26
- Terminated
- 2016-05-20
- Recalling firm
- Mylan Institutional LLC
- Firm location
- Rockford, IL