D-0859-2020 Class III Terminated
FDA drug recall D-0859-2020 was initiated by Akorn, Inc. on February 21, 2020 and is designated Class III. Reason for recall: Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. The recall status is terminated (terminated July 28, 2022). Affected quantity: 720 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2020
- Initiation Date
- February 21, 2020
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 720 tubes
Product Description
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Reason for Recall
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Distribution Pattern
Nationwide within United States and Puerto Rico
Code Information
Lot #: 8B66A, Exp. Date 01/2021; Lot 8C91A, Exp. Date 02/2021; Lots 8F07A, 8F16A, Exp. Date 05/2021; Lot 8F13A, Exp. Date 07/2021.