Contamination prompts voluntary injectables recall



Mylan N.V. has announced a voluntary recall of specific lots of injectable products for conditions including rheumatoid arthritis, severe psoriasis, lung cancer, breast cancer, ovarian cancer, and acute nonlymphocytic leukemia because foreign particles were observed during testing of retention samples, according to a statement issued by the company on April 23.

The specific lot numbers can be found on the company’s website.

Affected products include methotrexate injection, USP 25 mg/mL, which is indicated for adult rheumatoid arthritis, severe psoriasis, and some neoplastic diseases. According to Mylan, the contaminated lot was distributed in the United States between Jan. 16, 2014, and March 25, 2014.

Other recalled injectable products include gemcitabine, USP 200 mg, an intravenous product for ovarian cancer, breast cancer, non–small cell lung cancer, and pancreatic cancer; carboplatin 10 mg/mL, indicated for advanced ovarian cancer; and cytarabine, indicated for remission induction in acute nonlymphocytic leukemia in adults and children. The lots for these products were distributed in the United States in various periods of several months during 2014.

The recall is being conducted with the knowledge of the Food and Drug Administration, and any adverse events or quality problems should be reported to the FDA’s MedWatch adverse event reporting program.

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