Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
Mylan Pharmaceuticals, a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), due to the potential for a missing label in the batch. The product is packaged in a 10 mL vial that is inside a carton. The label may be missing on some vials, and the product information, batch number and expiry date information are present on the carton. The product is meant as a treatment for adults and pediatric patients with type 1 diabetes mellitus and for adults with type 2 diabetes mellitus.
The recall does not pertain to the branded interchangeable biosimilar, Semglee injection, but the unbranded Insulin Glargine-yfgn vial. The impacted batch was manufactured by Biocon Sdn. Bhd and was distributed by Mylan Specialty L.P. in the United States between Dec. 9, 2021 and March 4, 2022.
A missing label on Insulin Glargine vials has the potential to lead to a mix-up of products/strengths, which may result serious complications due to less optimal glycemic control (either high or low blood sugar), especially in patients receiving treatment with more than one type of insulin, according to the company. No adverse events related to the recall have been received by the company to date.
The company has initiated the recall of the batch, batch BF21002800, and notified its distributers and retailers by letter requesting for the return of all recalled products.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
