Mylan Initiates Voluntary Recall of Methotrexate Lot #7801082

On April 23, 2015 Mylan N.V. announced that it is conducting a voluntary nationwide recall for select lots of several injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.

This includes a recall for Methotrexate Injection, which may affect individuals with Rheumatoid Arthritis. The affected Lot Number for Methotrexate Injection, USP 25mg/mL (NDC 0069-0146-02) is # 7801082 with an expiration date of 07/2015.

Lot # 7801082 was distributed in the United States over a year ago between January 16, 2014 and March 25, 2014. This lot was packaged by a Mylan company, Agila Onco Therapies Limited, and has a Pfizer Injectables label.

The lot number can be found on the upper right hand corner of the bar code label that is on all Mylan products.

Administering injectable solution that contains foreign particulates carries the risk of severe health complications and potentially life threatening consequences. Therefore, if the bar code on your injectable Methotrexate indicates that it is from lot # 7801082, do NOT inject this medicine.

If you have questions regarding this recall, you can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com Monday through Friday from 8 a.m. – 5 p.m. EST.

If you have experienced problems that may be related to methotrexate, please make sure you contact your physician or healthcare asap.

Adverse reactions or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: Download/submit the online form
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

You can find additional information regarding the recalled products at the FDA’s website and on Mylan’s press release.