Reported Jan 26, 2022 · Terminated

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3…

Mylan Pharmaceuticals Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc · 3711 Collins Ferry Rd · Morgantown, WV · 26505-2362

Is this the product you have?

  • Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only
  • Manufactured in Malaysia forMylan Specialty L.P., Morgantown, WV, 26505
Lot codes and dates
    • Batch # BF20003118
    • Exp. August 2022
Amount recalled
73,175 prefilled pens

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 12, 2024 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.