Mylan has recalled an injectable drug that reduces the side effects of chemotherapy.
The drug is Levoleucovorin Injection 250 mg/25 mL. It’s commonly prescribed to treat the serious side effects of high doses of methotrexate, a type of chemotherapy used to treat cancers like osteosarcoma and advanced colorectal cancer. It helps lower the toxicity of methotrexate and counteract side effects.
This is a voluntary, nationwide recall of two lots of levoleucovorin injection that were manufactured by Indian drugmaker Alidac Pharmaceuticals Limited, and were distributed by Mylan Institutional LLC in the U.S. between August 2017 and July 2018.
This recall is for 25 ml, single-use vials Levoleucovorin Injection 250 mg/25 mL that have the lots numbers: APB032 and APB033 with NDC# 67457-601-30. They expire in April of 2019.
Copper salts were found in samples of the drug during a 12-month stability testing. Potential health consequences include:
- local irritation
- antigenic or allergic reactions
- microvascular obstruction, including pulmonary embolism.
As of this writing, Mylan has not received any reports of adverse side effects from consumers due to these specific lots.
If you have any questions, contact Mylan Customer Relations at 800.796.9526, Monday through Friday from 8:00 AM to 5:00 PM EST, or email customer service at or email@example.com.
If you experience any of the side effects listed that may be related to using the drug, contact your healthcare provider. You can also report any adverse reactions from this product to the FDA by submitting a form online here.
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