D-0860-2020 Class III Terminated
FDA drug recall D-0860-2020 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: 24 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
- 24 tubes
Product Description
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
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 #:8G59A, Exp. Date 06/2021