Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter
ROCKFORD, Ill-- Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL tothe consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. To date, Mylan has not received any reports of adverse events related to this recall.
Levoleucovorin injection is indicated for rescue after high-dose Methotrexate therapy in osteosarcoma; for diminishing the toxicity and counteracting the effects of impaired Methotrexate elimination and of 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.
Levoleucovorin Injection, 250 mg contains 25 mL sterile solution in a single-use vial.? Each vial is packaged in a carton containing one single-use vial. The batches?were distributed in?the?U.S. between?August?2017 and?July?2018.?The recalled?lots?are as?follows:
|
NDC |
Product?Description?and?Strength |
Size |
Lot?number |
Expiry |
|
67457-601-30 |
Levoleucovorin?Injection?250?mg/25?mL |
25?mL?vial |
APB032 |
April?2019 |
|
67457-601-30 |
Levoleucovorin?Injection?250?mg/25?mL |
25?mL?vial |
APB033 |
April?2019 |
- Wholesaler:?Immediately examine your inventory, quarantine and discontinue distribution of these lots. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan7079@stericycle.com within 10 business days. Stericycle will notify your retail level customers that received the affected batches.
- Retailer:?Immediately examine your inventory, quarantine and discontinue distribution of these lots. Additionally, if you have further distributed the product, please identify the consumer and notify them immediately of this product recall. The consumer should be instructed to contact Stericycle at 1-866-551-2706 for the documentation packet to return the product.
- Consumer:?Please contact Stericycle at 1-866-551-2706 for the documentation packet to return product to Stericycle.
- Complete and?submit the report Online:?www.fda.gov/medwatch/report.htm
- Regular?Mail or Fax: Download?form?www.fda.gov/MedWatch/getforms.htm?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.
