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 # BF20003118Exp. 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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