FDA Recall D-1331-2015
Mylan Institutional LLC · Rockford, IL
Class I — life-threatening Terminated 428 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
Reason for recall
Presence of Particulate Matter
Recall record
- Recall number
D-1331-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2015-03-18
- Classified by FDA Center
- 2015-08-14
- FDA published
- 2015-08-26
- Terminated
- 2016-05-19
- Recalling firm
- Mylan Institutional LLC
- Firm location
- Rockford, IL