Voluntary Nationwide Recall of Levoleucovorin Injection

Article

Levoleucovorin injection is being recalled due to the presence of copper salts discovered during a 12-month stability testing.

Mylan is voluntarily recalling 2 lots of levoleucovorin injection to the consumer level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan. This levoleucovorin injection is being recalled due to the presence of copper salts discovered during a 12-month stability testing.

The following lots were recalled:

  • 67457-601-30. Levoleucovorin Injection 250 mg/25 mL; APB032; 25 mL vial; April 2019
  • 67457-601-30. Levoleucovorin Injection 250 mg/25 mL; APB033; 25 mL vial; April 2019

Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Mylan has not received any reports of adverse events related to this recall, the company said in a prepared statement.

Levoleucovorin injection is indicated for rescue after high-dose methotrexate therapy in osteosarcoma; for lessening the toxicity and counteracting the effects of impaired methotrexate elimination and for the inadvertent overdose of folic acid antagonists; and for the use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

Mylan has notified its distributors and customers by letter and is arranging for a return of all recalled products.

Wholesaler and retailers are instructed to immediately examine inventory, quarantine, and discontinue distribution of these lots.

In addition, wholesalers that have further distributed the product are instructed to identify retail level customers and provide a list of customers that received the affected batches. Retailers are instructed to identify consumers that received the affected batches and and notify them immediately of this product recall.

Consumers are being instructed to contact Stericycle at 1-866-551-2706 for the documentation packet to return the product, and to contact Mylan Customer Relations at 800.796.9526 or email customer.service@mylan.com with questions regarding the recall. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product.

Reference

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter [news release]. Rockford, Illinois. Mylan website. Published March 18, 2019. http://investor.mylan.com/news-releases/news-release-details/mylan-institutional-llc-initiates-voluntary-nationwide-recall. Accessed March 18, 2019.

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