Recall archive / FDA drug enforcement
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug... — FDA record D-0547-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Quantity
- 136,005 units
- Agency-reported status
- Ongoing
- Source record identifier
- D-0547-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 19, 2024
- Recall initiation date
- May 14, 2024
- Center classification date
- Jun 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.