FDA MedWatch - One Batch of Semglee (insulin glargine injection) Prefilled Pens by Mylan Pharmaceuticals

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TOPIC: One Batch of Semglee (insulin glargine injection) Prefilled Pens by Mylan Pharmaceuticals: Recall - Due to the Potential for a Missing Label in the Batch

AUDIENCE: Health Professional, Pharmacy, Endocrinology, Patient 

ISSUE: Mylan Pharmaceuticals is recalling one batch, BF20003118, of its non-interchangeable Semglee (insulin glargine injection), 100 units/mL (U-100), 3 mL prefilled pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.

A missing label on Semglee (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications.

To date, the company has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button Read Recall below.

BACKGROUND: 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. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

This recall does not pertain to the recently launched interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.  

RECOMMENDATIONS: 

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Patients who have an unlabeled product should contact Stericycle for the documentation packet to return product to Stericycle.
• Patients with questions regarding this recall can contact Viatris Customer Relations. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.