FDA-Drug2022-08-03Class I

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

Mylan Pharmaceuticals Inc
Hazard

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

Sold states
Product was distributed nationwide within the United States
Affected count
253,200 pens (50,650/5 per packs)
Manufactured in
5005 Greenbag Rd, Morgantown, WV, United States
Products
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1292-2022

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