FDAFDA · Food and drugs·Recall number D-0462-2022
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.
Published January 26, 2022 · Recall initiated: January 5, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Missing Label: label missing from some Semglee prefilled pens.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- Nationwide in the USA and Thailand.
- Lot
- Batch # BF20003118, Exp. August 2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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