FDA recall D-0661-2017

Akorn, Inc. · Class II · drug

Product

LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12

Reason for recall

Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-17
Report date: 2017-04-19
Termination date: 2019-07-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2017