FDA recall D-1292-2022

Product

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

Reason for recall

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

Distribution

Product was distributed nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-07-05

Report date

2022-08-03

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

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