FDA Recall D-1293-2019
Par Pharmaceutical, Inc. · Chestnut Ridge, NY
Class I — life-threatening Terminated 1512 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
Reason for recall
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Recall record
- Recall number
D-1293-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- nationwide
- Recall initiated
- 2019-04-30
- Classified by FDA Center
- 2019-05-22
- FDA published
- 2019-05-15
- Terminated
- 2023-06-20
- Recalling firm
- Par Pharmaceutical, Inc.
- Firm location
- Chestnut Ridge, NY
Drug identification
- Brand name(s)
- MYCOPHENOLATE MOFETIL
- Generic name(s)
- MYCOPHENOLATE MOFETIL
- Manufacturer(s)
- Endo USA, Inc.
- NDC(s)
42023-172- Route(s)
- INTRAVENOUS