April 2019 FDA Recall Mycophenolate Mofetil by Par Pharmaceutical, Inc.
D-1293-2019 - Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
This Class I drug recall was voluntarily initiated by Par Pharmaceutical, Inc. on April 30, 2019 for the product Mycophenolate Mofetil. The FDA reported the reason for recall as presence of particulate matter; glass fragment observed in one vial of reconstituted product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1293-2019
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
04-30-2019
05-15-2019
4506 packs
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Par Pharmaceutical, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
nationwide
06-20-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# AD812, exp 9/2020
