FDA recall D-0462-2022

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA and Thailand.

Key facts

Status

Terminated

Initiation date

2022-01-05

Report date

2022-01-26

Termination date

2024-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0462-2022