Drug product
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
D-0861-2020
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 85018
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0861-2020
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 #:8G50A, Exp. Date 06/2021
Distribution pattern: Nationwide within United States and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter