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Mylan expands recall of select injectable product lots due to presence of particulate matter
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Mylan has expanded its voluntary recall to the hospital / user level for select lots of methotrexate, gemcitabine and other products designed for injection use due to the presence of visible particulate matter, according to a company press release.
The recall includes methotrexate injection USP 25 mg/mL designed for intramuscular, intravenous, intra-arterial or intrathecal injection, lot number 7801421. According to Mylan, the lot was distributed between Dec. 8, 2014, and Dec. 19, 2014, and packaged by Agila Onco Therapies Limited, a Mylan company. The lot’s expiration date is September 2016.
The other recalled medications — gemcitabine, carboplatin and cytarabine — were also manufactured by Agila Onco Therapies Limited during other time periods. Details regarding the lot numbers and expiration dates of the lots in question can be found on the FDA’s safety recall page. It is reported that Mylan is notifying its known distributors and customers by letter and is making arrangements for the return of all of the recalled products.
Physicians, clinicians, hospital professionals, retailers and distributors are advised to return the lot to the point of purchase, and anyone with questions should call Mylan customer relations at 800-796-9526 between the hours of 8 a.m. and 5 p.m. EDT, Monday through Friday, according to the press release.
Consumers are advised to contact their health care providers regarding any suspected problems related to the recalled products. Patients and health care professionals are encouraged to report any adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program through its website.
References: www.mylan.com, www.fda.gov.