May 21, 2022

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Viatris recalls Semglee insulin pens due to lack of label risk. 



 

 

Viatris recalls Semglee insulin pens due to lack of label risk. 

A few days ago, Viatris said it was voluntarily recalling a batch of Semglee, an insulin glargine injection pen.

The generic drug maker noted that the recall was announced because of possible missing labels on some of the Semglee pre-filled pens inside the label carton from a particular batch.

 

 

Viatris recalls Semglee insulin pens due to lack of label risk. 

 

 

Viatris said the company has not received any reports of adverse events related to the recall.

The batch in question was manufactured by Biocon and distributed in the U.S. by Mylan between May 11, 2021 and November 11, 2021, according to a notice posted by Viatris on the U.S. FDA website.

The recalled Insulin Glargine Pens Semglee Lot BF20003118 is a 100 units/ml (U-100) 3mL pen, containing 5 pens in each labelled carton, and will expire in August 2022.

 

At present, Viatris has not announced the number of injection pens specifically involved in the recall.

However, the company warns that the missing label on the Semglee prefilled pens could lead to the use of the wrong insulin in patients receiving more than one type of insulin, such as short-acting and long-acting insulin.

Poor blood sugar control (hyperglycemia or hypoglycemia) can lead to serious complications when a patient uses the wrong insulin.

Not only can this impede blood sugar control, which can lead to serious health risks.

 

It is worth noting that Viatris specifically emphasized that the recalled products have nothing to do with its recently launched interchangeable biosimilars, the branded product Semglee injection or the unbranded product Insulin glargine injection.

At present, the company has initiated a recall action for batch BF20003118, and has notified its distributors and retailers in writing, and is arranging the return of all recalled products, and informs consumers that if they find unlabeled products, they should call immediately. concerned department.

 

On July 29 last year, the US FDA approved Viatris’s Semglee (generic insulin glargine-yfgn) as an exchangeable biosimilar of Sanofi’s long-acting insulin Lantus, which is also the first FDA approval of an exchangeable biosimilar. The first approved alternative biosimilar insulin for diabetes.

In the first three quarters of last year, Lantus had global sales of 1.9 billion euros ($2.2 billion), but U.S. sales of its diabetes drug fell 13 percent.

However, Sanofi has been counting on its patents to help it block sales of rival insulin treatments.

 

However, at the end of last year, according to information on Viatris’s official website, the U.S. Court of Appeals for the Federal Circuit extended the previous ruling of the U.S. Patent and Trademark Appeals Board and ruled that five patents for Sanofi’s best-selling Lantus insulin injection pen device were invalid.

The decision reinforces the company’s ongoing efforts to break down barriers to patient access to important medicines such as Semglee, Facilitate said in a press release at the time.

 

Viatris was born in late 2020 as a result of the merger of the Mylan and Pfizer Upjohn divisions.

This packaging confusion is a serious concern in the pharmaceutical world, but a lack of labelling may not be the worst outcome. Last year, generic drug maker Meitheal Pharmaceuticals recalled a shipment of the muscle relaxant cisatracurium besylate due to an extremely dangerous packaging error after the company received complaints that the drug’s carton was covered in Mislabeled phenylephrine hydrochloride, which is indicated for the treatment of hypotension.

Although Meitheal said it did not receive any reports of side effects related to the recall at the time, patients who misused it could cause irreparable damage.

 

 

 

 


Reference source:

1. Viatris yanks one batch of diabetes med Semglee because of missing label risks

2.Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch

Viatris recalls Semglee insulin pens due to lack of label risk. 

(source:internet, reference only)


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