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:
|NDC #||Name and Strength||Size||Batch#||Expiry|
|49502-196-75||Semglee® (insulin glargine injection),|
100 units/mL (U-100)
|3mL Prefilled Pen||BF20003118||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 wholesalers, retailers and consumers:
- Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to email@example.com within 10 business days. Stericycle will notify your retail level customers that received the affected batch.
- Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
- Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.
Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526 or firstname.lastname@example.org, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Original recall and updates at FDA