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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Mylan Pharmaceuticals Inc 2022-01-26 Health critical FDA
Health · FDA · Recall #FDA-D-0462-2022

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC… Recall

Issued January 26, 2022 · Mylan Pharmaceuticals Inc

In January 2022, Mylan Pharmaceuticals Inc recalled the Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Labeling: Missing Label: label missing from some Semglee prefilled pens.

What you should do

  1. 1 Stop using Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Mylan Pharmaceuticals Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Mylan Pharmaceuticals Inc
Category
Health
Recall date
January 26, 2022
Units affected
Not reported
Sold at
Nationwide in the USA and Thailand.
Recall number
FDA-D-0462-2022
Made in
United States
Issuing agency
FDA

In context

  • Mylan Pharmaceuticals Inc has 4 recalls in our database, including 3 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 870th Health recall we've logged in 2022.
Read the official FDA notice

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