Class II · Moderate risk
Myxredlin
CGMP Deviations
Semglee (insulin glargine)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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 for: Mylan Specialty L.P., Morgantown, WV, 26505.
Affected NDCs
49502-0196-71
49502-0196-75
Compare with the code on your package — it is the most precise check available.
Drug: Insulin Category: Diabetes Medication
- Recalling firm
- Mylan Pharmaceuticals Inc
- NDC code
- 49502-0196-71
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jan 18, 2022 · FDA notice with lot numbers
- FDA recall number
- D-0462-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Other recalls by Mylan Pharmaceuticals Inc
All 2022 recalls
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Class II · Moderate risk
Prasugrel Tablets
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Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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