FDA recall D-1293-2019

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

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2019-04-30

Report date

2019-05-15

Termination date

2023-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1293-2019