According to the U.S. Food and Drug Administration, Mylan recalled injectable products due to the presence of a particulate matter. The nationwide recall involves hospital and user level products.
A visible foreign particulate matter was observed during retention sample testing. Injectable products affected by the recall include Gemcitabine, Carboplatin, Methotrexate, and Cytarabine injection. These injectable products came in 2, 5, 10, 50 and 100-milliliter sizes.
The Gemcitabine for injection is used as a treatment of breast, ovarian, and pancreatic cancers as well as non-small cell lung. They were distributed from Feb. 18, 2014 to Dec. 19, 2014. Carboplatin injection is administered to treat advanced ovarian carcinoma and was sold between the dates Aug. 11, 2014 and Oct. 7, 2014.
Methotrexate injection is administered for severe psoriasis, adult rheumatoid arthritis, and some neoplastic diseases. The injectable was distributed between Jan. 16, 2014 and March 25, 2014. Cytarabine injection is used with other medications to treat acute non-lymphocytic leukemia and distributed from May 2, 2014 to July 24, 2014.
The press release indicated foreign particulates have the potential to lead to adverse and even deadly consequences. Individuals may suffer from inflammation, infection, embolization in the body, damage to blood vessels and even long-term granuloma formation. Additionally, some individuals may suffer respiratory failure, loss of renal function, stroke, myocardial infarction or an allergic reaction.
The contamination of these injection products poses a substantial threat to the health and safety of the patients who are treated with these products.
Mylan is not aware of any incidents or injuries caused by infected products.
The FDA noted sterility of pharmaceutical equipment is of utmost importance. All injectable drugs must be sterile.