Semglee FDA Alerts

Mylan Pharmaceuticals Inc. Issues Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens U-100, Due to the Potential of Missing Labels on Some Pens

PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.

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

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

• Wholesalers: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list via Microsoft Excel file to mylan8775@sedgwick.com within five (5) business days. Sedgwick will notify your retail level customers that received the affected batch.
• Retailers: Immediately examine your inventory, quarantine and discontinue distribution of this batch. In addition, if you have further distributed the subject batch, please identify the consumer and notify them of this product recall and to immediately return any unlabeled product per the instructions below.
• Consumers: If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 37,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

Source: FDA

Mylan Issues Voluntary Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label

April 12, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

The company has initiated the recall of batch BF21002800 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

• Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list of customers via Microsoft excel file to mylan5889@sedgwick.com within 5 business days. Sedgwick (Stericycle) will notify your retail level customers that received the affected batch.
• Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
• Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-912-7084 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 37,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

Mylan 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

PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.

This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:

Risk Statement: A missing label on Semglee® (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilars, Semglee® (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens in cartons of five (5) pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

• Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan6069@sedgwick.com within 10 business days. Stericycle will notify your retail level customers that received the affected batch.
• Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
• Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download 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.

About Viatris

Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 38,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

Source: FDA

Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication

Audience:

• Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines.
• Health care providers who treat patients, or who train users on pen needles and pen injectors

Specialties

Health care providers including Nurses, Nurse Practitioners, Physician Assistants, Health Educators, Pharmacists, and Physicians

Device

Pen needles are used to inject medicine with pen injectors. For example, when insulin is packaged in a multi-dose pen injector, a new pen needle is used each time to inject the insulin.

Common types of pen needles include standard pen needles and safety pen needles. Standard pen needles often have an outer cover and a removable inner needle cover, which are both removed before an injection. Safety pen needles are different. They have an outer cover that is removed, and a fixed inner needle shield that is not removed before an injection.

Standard pen needles often have an outer cover and a removable inner needle cover. Both the outer cover and the inner needle cover must be removed before an injection.

Safety pen needles have an outer cover and a fixed inner needle shield (sharps injury prevention feature). The outer cover is removed before an injection, but the fixed inner needle shield is NOT removed before an injection.

Purpose

The FDA is providing recommendations to patients, caregivers, and health care providers to promote the safe use of pen needles used to inject medicines from pen injectors.

Summary of Problem and Scope

Pen needles are used with pen injectors to inject different types of medicines. The same pen injector can be used with both standard and safety pen needles. It is possible that patients could be taught using one type of pen needle, then receive the other type later. This could cause confusion about how to use the pen needle correctly, and may prevent the patient from getting the medicine they need.

The FDA has received reports of patients using standard pen needles to inject insulin without removing the inner needle cover. In these cases, the inner cover stopped the needle from entering the skin and the patients did not get the insulin. Some patients developed high blood sugar (hyperglycemia) because the inner needle cover stopped them from getting insulin.  One patient was hospitalized and died because of having blood sugar that was too high for too long.   

To help people use pen needles safely, the FDA recommends these actions:

Recommendations for Patients and Caregivers

• Each time you get a new box of pen needles, check to see if they are the same type as the ones you were trained to use. If not, ask your health care provider to show you how to use this new type properly.
• If you use a standard pen needle with an outer cover and an inner needle cover, be sure to remove both covers before use.
• If you feel like your medicine from the pen injector is not working, talk to your health care provider.
  • For example, if you have diabetes and your blood sugar levels are high after insulin injections, contact your health care provider to talk about your injection technique, insulin dosage, and other things that can affect your blood sugar levels.
• If you have any questions about your pen needle, contact your health care provider.

Recommendations for Health Care Providers and Health Care Educators

• Train and educate patients and caregivers:
  • Show them how to use the pen needle for their medication.
  • Ensure they can demonstrate correct technique to verify proper use of their pen needles.
  • Be sure they are aware of the different types of pen needles, and they know which type they use.
  • Explain the signs and symptoms of under-dose (and over-dose) of their medication, how to monitor their medical condition (for example, blood glucose levels), and when to contact their health care provider.
• Prescribers: Consider whether there could be a problem with an injection or medication administration technique before changing a medication dose.
• Pharmacists: When dispensing a new box of pen needles, consider asking the patient if they know how to use the type of pen needles being dispensed.
  • For example, remind patients that:
    • For standard pen needles with an outer cover and an inner needle cover, remove both covers before use.
    • For the safety pen needle, remove only the outer cover, as the fixed inner needle shield remains in place.
  • Be available to answer questions from patients and caregivers or refer them to their applicable health care provider.

FDA Activities

The FDA asked pen needle manufacturers to review their most recent labeling (that is Instructions or Directions for Use) and training materials to assess the need for updates to clearly explain how to use the pen needle safely. In addition, the FDA requested that standard pen needle manufacturers consider adding a warning in the labeling regarding the need to remove both the outer cover and the inner needle cover before use.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect or experience a problem with a pen needle, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Be sure to include:

• Device manufacturer and model of the pen needle
• The name of the medication being delivered through the pen needle (for example, the name of the pen injector)
• A clear description of event or issue and any applicable patient outcomes

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Other Resources

• Institute for Safe Medical Practices, Severe Hyperglycemia in Patients Incorrectly Using Insulin Pens at Home
• Truong, T. H., Nguyen, T. T., Armor, B. L., & Farley, J. R. (2017). Errors in the Administration Technique of Insulin Pen Devices: A Result of Insufficient Education. Diabetes Therapy, 8(2), 221–226. https://doi.org/10.1007/s13300-017-0242-y
• American Diabetes Association
• NIH - Diabetes

Contact Information

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.