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Mylan Pharma Recalls Unbranded Insulin Glargine Injection Pens

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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.

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.

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.

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.

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.

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.

However, the company has not received any adverse events related to the recalled product to date.

The company has urged distributors and retailers to discontinue distribution of the batch subject to recall, and asked consumers to return the unlabeled pen.

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.

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