Mylan Pharmaceuticals Recalls Batch Of Insulin Glargine Injection Product Over Missing Label Concerns

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Mylan Pharmaceuticals Insulin Glargine Injection Recall Overview: 

• Who: Mylan Pharmaceuticals has voluntarily recalled one batch of its Insulin Glargine Injection, 100 units/mL (U-100), product. 
• Why: The recall was initiated over concerns some of the vials in the batch could be missing a label. 
• Where: The recall is nationwide.

Mylan Pharmaceuticals has issued a voluntary recall for one batch of its Insulin Glargine Injection, 100 units/mL (U-100), product, after discovering some vials may be missing a label. 

The recalled product is an unbranded version and is packaged in a 10 mL vial located inside of a carton, according to a recall notice published by the US Food and Drug Administration (FDA) on Apr. 12. 

The Semglee branded version of the drug is not affected, according to the recall, which says the recalled Insulin Glargine Injection product was distributed nationwide between Dec. 9, 2021 and Mar. 4, 2022. 

Mylan, a Viatris company, says missing labels on some of the Insulin Glargine vials could lead to patients not knowing the strength of the product, ultimately causing “serious complications.” 

The drug manufacturer says it has so far not received any reports of adverse events occurring that would be related to the recall, according to the notice.

Mylan’s Insulin Glargine Injection product is used to “improve glycemic control” in adults and pediatric patients suffering from type 1 and type 2 diabetes mellitus, according to the recall. 

Mylan Has Notified Distributors, Retailers About Insulin Glargine Injection Recall

Mylan says it has notified both distributors and retailers who carry it about the recall and arranged for the affected Insulin Glargine Injection products to be returned. 

Consumers who have an unlabeled product are being asked to contact Stericycle at 1-888-912-7084 to provide documentation that will allow them to return the product to Stericycle. 

Mylan is also advising retailers and wholesaler sellers to “immediately examine” their inventory and quarantine and discontinue use of the recalled product, according to the recall notice. 

Wholesalers are further being asked to provide a list of all customers, including those on the retail level, to the company. 

Consumers who have more questions about the recall can contact Viatris Customer Relations directly by email or by phone at 1-800-796-9256. 

Just last month, Mylan agreed to pay $264 million to resolve claims it worked together with Pfizer to raise the price of the EpiPen. 

Do you own the recalled Insulin Glargine Injection product? Let us know in the comments! 

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