FDA Recall D-1329-2015
Mylan Institutional LLC · Rockford, IL
Class I — life-threatening Terminated 433 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
Reason for recall
Presence of Particulate Matter
Recall record
- Recall number
D-1329-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-04-23
- Classified by FDA Center
- 2015-08-13
- FDA published
- 2015-08-19
- Terminated
- 2016-06-29
- Recalling firm
- Mylan Institutional LLC
- Firm location
- Rockford, IL