Medications & Supplements/Prescription Drugs

Par Pharmaceutical, Inc.: Mycophenolate Mofetil for Injection Recalled Due to Glass Fragment Presence

Agency Publication Date: May 7, 2019

Summary

Par Pharmaceutical is recalling 4,506 packs of Mycophenolate Mofetil for Injection, USP 500 mg (generic CellCept), which is an immunosuppressant medication. The recall was initiated after a glass fragment was discovered in one vial of the product after it was prepared for use. Using this product could cause serious health complications if glass particles are accidentally injected into a patient.

Risk

If glass fragments or particulate matter are present in an injectable medication, they can cause local irritation, inflammation, or more severe internal injuries such as blood vessel blockages (embolism) or organ damage if the particles travel through the bloodstream.

What You Should Do

Check your medication vials for Mycophenolate Mofetil for Injection, USP 500 mg with the lot number AD812 and an expiration date of 9/2020.
Immediately stop using any vials from the affected lot (AD812) and set them aside to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist immediately for guidance if you have this medication or if you have recently received an injection from this lot.
Return any unused product from lot AD812 to your pharmacy to receive a refund and further instructions.
Contact Par Pharmaceutical at 1 Ram Ridge Rd, Chestnut Ridge, NY 10977 for more information regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Mycophenolate Mofetil for Injection, USP 500 mg (4 Single Dose Vials)

Model:

NDC 342023-172-044

Recall #: D-1293-2019

Lot Numbers:

AD812 (exp 9/2020)

Date Ranges: September 2020

Product Images

Label, Mycophenolate Mofetil for injection

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82680

Status: Resolved

Manufacturer: Par Pharmaceutical, Inc.

Sold By: Par Pharmaceutical

Manufactured In: United States

Units Affected: 4506 packs

Distributed To: Nationwide

Agency Last Updated: May 22, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for Mycophenolate Mofetil for Injection, USP 500 mg with the lot number AD812 and an expiration date of 9/2020.

Immediately stop using any vials from the affected lot (AD812) and set them aside to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist immediately for guidance if you have this medication or if you have recently received an injection from this lot.

Return any unused product from lot AD812 to your pharmacy to receive a refund and further instructions.

Contact Par Pharmaceutical at 1 Ram Ridge Rd, Chestnut Ridge, NY 10977 for more information regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.