Last Updated on October 6, 2024 by The Health Master
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 labeled 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:
| NDC # | Name and Strength | Size | Batch# | Expiry |
|---|---|---|---|---|
| 49502-196-75 | Semglee® (insulin glargine injection), 100 units/mL (U-100) | 3mL Prefilled Pen | BF20003118 | August 2022 |
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-acting and long-acting insulin), could lead to a mix-up of products/strengths, resulting in the 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (USFDA).
Drug recall: Sun Pharma, Lupin recall these drugs
Drug recall: Clobetasol Propionate Ointment recalled due to this reason
Drug recall: Torrent recalls 27,000 bottles of BP lowering drug
Drug recall: Lupin recalls 4,113 cartons of oral contraceptive
Drug recall: Aurobindo, Unichem recall these drugs from the market
Drug recall: Sun Pharma recalls about 1.10 lakh bottles of Tadalafil in US market
Govt issued draft notification to amend Rule 43 of MD Rules 2017
Budget 2022: Pharma industry seeks Ease of Doing Business
Cosmetic mfr can’t be mandated to put veg, non-veg labels: HC
Pharma park MoU for Rs 750 crore signed
USFDA gives conditional nod to Glenmark for generic Regadenoson injection
New Medical Device developed for 6 tests in 60 seconds without prescription
Govt to allow sale of these Medicines with out Prescription
Drug alert: 33 out of 1385 samples declared as NSQ in December 2021
Pharmaceutical Budget 2022: Expectations
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
