On July 5, 2022, Mylan Pharmaceuticals Inc, a Viatris Company, issued a voluntary recall of one batch of Insulin Glargine Injection, 100 units/ml, 3mL prefilled pens, which were packaged in cartons of five injection pens to the consumer level.
However, the recalled product is not the branded Semglee pen but the unbranded Insulin Glargine-yfgn pens. The batch was recalled due to the potential for the accompanying label missing on some pens.
This is a potentially serious health risk for patients receiving treatment with more than one type of insulin since it could result in a mix-up.
A simple mix-up of short and long-acting insulin may result in less optimal glycemic control leading to serious health complications. To date, no adverse effects relating to this recall have been reported to the Food and Drug Administration (FDA).
Consumers should note that the recall only affects the unbranded interchangeable biosimilar Insulin Glargine-yfgn and not the branded biosimilar Semglee injection pens.
The recalled product is a long-acting human insulin analog designed to improve glycemic control in pediatric and adult patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The insulin injection pens are usually packaged in a 3mL prefilled pen, then packaged in cartons of five pens.
The batch number, expiry date, and production information are usually printed on the carton. Biocon Sdn manufactured the affected batch. Bhd and distributed by Mylan Specialty LP in the United States between April 4, 2022, and May 5, 2022. The recalled batch expires in August 2023, and the affected Batch number is BF21002895.
The Recall Process
The company initiated the recall of the affected batch by notifying its distributors, wholesalers, and retailers by letter and arranging for the return of all the affected products.
The wholesalers are required to examine their inventory, quarantine, and discontinue distribution of all the affected products.
If the wholesaler has already distributed the recalled products, they are required to identify the buyers, including the retailers, and send the details to Mylan via [email protected]. Sedgwick will notify the retail level customers that received the affected products about the recall.
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All retailers who may have ordered the affected products are also required to examine, quarantine, and discontinue further distribution of the products to the end user. If they have already sold the products to consumers, they are required to notify them of the recall and request them to return any unlabeled product to the manufacturer immediately.
Consumers who may have purchased the unlabeled insulin injection pens are required to contact Sedgwick via 1-877-643-8438 for the documentation packet to return the recalled product.
Consumers with questions regarding this recall are advised to contact Viatris Customer Relations Department via 1-800-796-9526 or email at [email protected]. The communication lines are open from Monday to Friday, 8:00 am to 5:00 pm EST.
Be sure to contact your primary healthcare provider if you have experienced any problems related to taking or using the recalled product.
You can also report any adverse effects experienced after using the recalled product to the FDA’s MedWatch Adverse Event Reporting program by either of the following methods:
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Download the 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.
Viatris is a relatively new kind of healthcare company that aims to empower people worldwide to live healthier lives at every stage.
They are a leading global provider of medicines and technologies that help patients live their lives to the fullest by addressing unmet healthcare needs throughout the continuum of care – from preventative wellness and diagnosis to treatment and home-based patient care.
They are a team of over 30,000 strong – including colleagues, scientists, clinicians, pharmacists, engineers, and many others – who work together to turn breakthroughs in science and technology into medicines that profoundly impact people’s lives.
They aspire to be the patient’s first choice for healthcare by delivering high-quality products and services that meet their needs and exceed their expectations.