Drug product
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
D-0859-2020
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 85018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 720 tubes
- Official record key
drug-enforcement:D-0859-2020
Official wording
Reason: 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.
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.
Distribution pattern: Nationwide within United States and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter