FDA recall D-0091-2019

Westlab Pharmacy, Inc. dba Westlab Pharmacy · Class II · drug

Product

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

Reason for recall

Lack of Process Controls

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-08-10
Report date
2018-10-31
Termination date
2020-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0091-2019