Mylan Prescription drugs Inc., a Viatris Firm, Points Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 models/mL (U-100), As a result of Potential of Lacking Labels on Some Pens

Abstract

Firm Announcement

UPDATED PRESS RELEASE: Mylan Prescription drugs, Inc. 8/9/2022

FOR IMMEDIATE RELEASE – PITTSBURGH – July 5, 2022 – Mylan Prescription drugs Inc., a Viatris firm, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 models/mL (U-100), 3 mL prefilled pens that are packaged in cartons of 5 pens to the patron degree. This product is just not the branded Semglee® pen however the unbranded Insulin Glargine-yfgn pens. This batch is being recalled as a result of potential for the label to be lacking on some pens.

Danger Assertion: For sufferers receiving remedy with a couple of kind of insulin (e.g., each brief and long-acting insulin), a lacking label on Insulin Glargine pens may result in a mix-up of merchandise/strengths, which can end in much less optimum glycemic management (both excessive or low blood sugar) which may end in critical problems. So far, no opposed occasions associated to this recall have been acquired for this product.

This recall pertains solely to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and doesn’t influence the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This product is a long-acting human insulin analog indicated to enhance glycemic management in adults and pediatric sufferers with kind 1 diabetes mellitus and in adults with kind 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of 5 pens. The product info, batch quantity and expiry date info are current on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. within the US between April 4, 2022 and Might 5, 2022. The recalled batch info is as follows:

The corporate has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled merchandise. Following are actions for wholesalers, retailers and customers:

• Wholesalers: Instantly look at your stock, quarantine, and discontinue distribution of the batch topic to recall. As well as, if in case you have additional distributed the product, please establish all prospects, together with retail degree prospects, and supply a listing by way of Microsoft Excel file to [email protected] inside 5 (5) enterprise days. Sedgwick will notify your retail degree prospects that acquired the affected batch.
• Retailers: Instantly look at your stock, quarantine and discontinue distribution of this batch. As well as, if in case you have additional distributed the topic batch, please establish the patron and notify them of this product recall and to right away return any unlabeled product per the directions under.
• Customers: If in case you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Customers with questions relating to this recall can contact Viatris Buyer Relations by telephone at 1-800-796-9526 or by e-mail at [email protected], Monday by means of Friday from 8 a.m. – 5 p.m. EST. Customers ought to contact their doctor or healthcare supplier if they’ve skilled any issues which may be associated to taking or utilizing this drug product.

Hostile reactions or high quality issues skilled with using this product could also be reported to the FDA’s MedWatch Hostile Occasion Reporting program both on-line, by common mail or by fax.

This recall is being carried out with the data of the U.S. Meals and Drug Administration.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a brand new type of healthcare firm, empowering folks worldwide to stay more healthy at each stage of life. We offer entry to medicines, advance sustainable operations, develop progressive options and leverage our collective experience to attach extra folks to extra services by means of our one-of-a-kind World Healthcare Gateway®. Fashioned in November 2020, Viatris brings collectively scientific, manufacturing and distribution experience with confirmed regulatory, medical, and industrial capabilities to ship high-quality medicines to sufferers in additional than 165 nations and territories. Viatris’ portfolio includes greater than 1,400 authorised molecules throughout a variety of therapeutic areas, spanning each non-communicable and infectious illnesses, together with globally acknowledged manufacturers, complicated generic and branded medicines, a portfolio of biosimilars and a wide range of over-the-counter client merchandise. With a world workforce of roughly 37,000, Viatris is headquartered within the U.S., with international facilities in Pittsburgh, Shanghai and Hyderabad, India. Study extra at viatris.com and investor.viatris.com, and join with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

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