D-0661-2017 Class II Terminated
FDA drug recall D-0661-2017 was initiated by Akorn, Inc. on March 17, 2017 and is designated Class II. Reason for recall: Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. The recall status is terminated (terminated July 9, 2019). Affected quantity: 107,940 bottles.
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