D-1293-2019 Class I Terminated
FDA drug recall D-1293-2019 was initiated by Par Pharmaceutical, Inc. on April 30, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product The recall status is terminated (terminated June 20, 2023). Affected quantity: 4506 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2019
- Initiation Date
- April 30, 2019
- Termination Date
- June 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4506 packs
Product Description
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 Pattern
nationwide
Code Information
AD812, exp 9/2020