Mycophenolate Mofetil Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 42023-172
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mycophenolate Mofetil (NDC 42023-172). A significant event, classified as Class I, was initiated on Apr 30, 2019 by Par Health Usa, Llc. The reported reason for this action was: "Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2019 Class I Recall: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Recall Number
Class I Terminated
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Apr 30, 2019
May 15, 2019
4506 packs
Recall Profile & Regulatory Data
Event ID
82680
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Par Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Jun 20, 2023
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
Batch or Lot Expiration Information
Lot# AD812, exp 9/2020
Affected Packages Involved in this Recall
42023-172-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
