D-0661-2017 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
April 19, 2017
Initiation Date
March 17, 2017
Termination Date
July 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
107,940 bottles

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.

Distribution Pattern

Nationwide

Code Information

Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17