FDA recall Z-0948-2021

Allergan PLC · Class II · device

Product

REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

Reason for recall

Missing Instruction For Use insert.

Distribution

U.S.: MO O.U.S.: None

Key facts

Status
Terminated
Initiation date
2020-12-29
Report date
2021-02-10
Termination date
2023-03-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0948-2021