Semglee Insulin glargine injection, 100 units/ml (U-100), 3mL prefilled pens - recalled due to Missing Label, USA

2 years ago •source www.fda.gov

Recall notice

United States

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) 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. This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:

- Semglee® (insulin glargine injection). Strenght: 100 units/mL (U-100). Size: 3mL Prefilled Pen. NDC #49502-196-75. Batch#: BF20003118. Expiry: August 2022

Risk Statement: 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.

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.

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 and is packaged in prefilled pens in cartons of five (5) pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for consumers, wholesalers, and retailers.

- Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.
- Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please check the link below for further actions.
- Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.

Company name: Mylan Pharmaceutical Inc.
Brand name: Semglee
Product recalled: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens
Reason of the recall: Missing Label
FDA Recall date: January 19, 2022

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #blood #us #sugar

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