Drug product
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
D-0547-2024
Product summary
- Event
- Event 94554
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136,005 units
- Official record key
drug-enforcement:D-0547-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot:23APR005 Exp. 5/1/2024 Lot:23MAY024 Exp. 5/15/2024 Lot:23JUN010 Exp. 5/30/2024 Lot:23JUN016 Exp. 6/7/2024 Lot:23JUN047 Exp. 7/4/2024 Lot:23JUL013 Exp. 7/11/2024 Lot:23JUL029 Exp. 7/25/2024 Lot:23JUL030 Exp. 8/1/2024 Lot:23AUG016 Exp. 8/7/2024 Lot:23AUG042 Exp. 9/27/2024 Lot:23SEP017 Exp. 7/13/2024 Lot:23OCT039 Exp. 8/3/2024 Lot:23NOV022 Exp. 8/24/2024 Lot:23NOV036 Exp. 8/29/2024 Lot:23DEC021 Exp. 10/4/2024 Lot:24JAN018 Exp. 10/11/2024 Lot:24JAN026 Exp. 10/24/2024 Lot:24JAN040 Exp. 11/2/2024 Lot:24FEB021 Exp. 11/16/2024 Lot:24MAR005 Exp. 12/12/2024
Distribution pattern: US Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility