FDA Med-Watch - One Batch of Insulin Glargine (Insulin glargine-yfgn) Recalled

TOPIC: One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL by Mylan: Recall - Due to the Potential of Missing Labels on Some Pens

AUDIENCE: Patient, Health Professional, Pharmacy, Endocrinology

ISSUE: Mylan Pharmaceuticals is recalling one batch, BF21002895, of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens. This product is not the branded Semglee pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications.

To date, no adverse events related to this recall have been received for this product.

This 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.

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

BACKGROUND: This 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.

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 pen should contact the company to return the product.
• Patients with questions regarding this recall can contact the company.

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