Drug 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
D-1293-2019
Product summary
- Event
- Event 82680
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4506 packs
- Official record key
drug-enforcement:D-1293-2019
Official wording
Reason: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Code information: AD812, exp 9/2020
Distribution pattern: nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter