Mylan Pharmaceuticals Inc., affiliated to healthcare company Viatris Inc., is recalling certain Insulin Glargine (Insulin glargine-yfgn) Injection prefilled pens due to the potential for the label to be missing on some pens, the U.S. Food and Drug Administration said.<\/p>\n
The recall involves one batch, BF21002895, of Insulin Glargine Injection, 100 units\/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens. The recalled batch comes with NDC # 49502-394-75, Batch # BF21002895 and expiry date of August 2023.<\/p>\n
The recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee (insulin glargine-yfgn) injection pens.<\/p>\n
The affected batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022.<\/p>\n
The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.<\/p>\n
According to FDA, a missing label on Insulin Glargine pens could lead to a mix-up of products\/strengths for patients receiving treatment with more than one type of insulin, such as both short and long-acting insulin. This may result in less optimal glycemic control, either high or low blood sugar, which could result in serious complications.<\/p>\n
However, the company has not received any adverse events related to the recalled product to date.<\/p>\n
The company has urged distributors and retailers to discontinue distribution of the batch subject to recall, and asked consumers to return the unlabeled pen.<\/p>\n
In January, Mylan had called back one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units\/ml (U-100), 3mL prefilled pens due to the potential for a missing label.<\/p>\n
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