FDA recall D-0845-2022

Product

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

Reason for recall

Labeling: Missing label on the vial

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2022-04-12

Report date

2022-05-04

Termination date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0845-2022