Mylan recalls cancer and arthritis injectables
Gemcitabine is an IV drug for the treatment of ovarian, breast, pancreatic, and non-small cell lung cancers.
The affected lots were distributed in the US between January 8, 2014, and February 10, 2015, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801084 and 7801110 are packaged with a Pfizer Injectable label.
Methotrexate is an injection for intramuscular, intravenous, intra-arterial, or intrathecal administration. It is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The faulty vials were distributed in the US between December 8, 2014, and December 19, 2014, also packaged by Agila Onco Therapies.
The recall affects the following lots:
NDC Number | Product Name and Strength | Package Size | Lot Number | Expiration Date |
0069-3857-10 | Gemcitabine for Injection, USP 200 mg | 10 mL | 7801084 | 07/2015 |
0069-3857-10 | Gemcitabine for Injection, USP 200 mg | 10 mL | 7801110 | 08/2015 |
67457-463-02 | Gemcitabine for Injection, USP 2 g | 100 mL | 7801221 | 03/2016 |
67457-464-20 | Gemcitabine for Injection, USP 200 mg | 10 mL | 7801398 | 08/2016 |
67457-464-20 | Gemcitabine for Injection, USP 200 mg | 10 mL | 7801406 | 08/2016 |
67457-464-20 | Gemcitabine for Injection, USP 200 mg | 10 mL | 7801427 | 09/2016 |
67457-462-01 | Gemcitabine for Injection, USP 1 g | 50 mL | 7801284 | 05/2016 |
67457-467-99 | Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL) | 5 x 2 mL | 7801421 | 09/2016 |
Mylan said it has not received reports of adverse events in patients related to the defective products. It added administration of a sterile injectable with foreign particulates can obstruct blood vessels and lead to emboli, myocardial infarction, respiratory failure, kidney and liver failure, or tissue necrosis.
