Mylan Pharmaceuticals recalls insulin glargine due to potential for missing label
Mylan Pharmaceuticals, Inc. has announced a recall of one batch of its 100 units/mL insulin glargine injection due to a potential missing label on some vials, according to a press release.
The recall affects batch BF21002800 of Mylan’s unbranded insulin glargine-yfgn, a long-acting insulin analog used to improve glycemic control for adults and children with type 1 diabetes and adults with type 2 diabetes. The recall affects only the unbranded insulin glargine-yfgn and not the branded Semglee vial.
For patients receiving more than one type of insulin, the missing label could lead them to mix up insulin formulations or strengths, potentially leading to less optimal glycemic control and serious complications.
No adverse events related to the recall have been reported. Anyone with an adverse event or quality problems with the product can report it to the FDA’s MedWatch Adverse Event Reporting program at www.fda/medwatch/report.htm.
Mylan Pharmaceuticals has notified its distributors and retailers and is arranging for a return of all recalled products. Consumers who have an unlabeled product can contact Stericycle at 1-888-912-7084 to receiving a documentation packet to return the product.
Anyone with questions regarding the recall is asked to contact Viatris customer relations at 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. to 5 p.m. Eastern. Patients experiencing any problems related to taking the product should contact their physician or health care provider.
This recall is being conducted with the knowledge of the FDA.
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