FDA-Drug2022-01-26Class I
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.
Mylan Pharmaceuticals Inc
Hazard
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Sold states
Nationwide in the USA and Thailand.
Affected count
73,175 prefilled pens
Manufactured in
3711 Collins Ferry Rd, N/A, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0462-2022Don't want to check this manually?
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