PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 19, 2017 Initiated: March 17, 2017 #D-0661-2017

Product Description

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.

Details

Recalling Firm
Akorn, Inc.
Units Affected
107,940 bottles
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 107,940 bottles.
Why was this product recalled?
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 19, 2017. Severity: Moderate. Recall number: D-0661-2017.