CLASS II ONGOING Drug recall · Reported 19 Jun 2024 · FDA Enforcement Report
Klarity-C (cyclosporine) Preservative-Free Sterile recalled
Imprimis Njof is recalling Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1%, distributed nationwide in the US. The recall was initiated on 14 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0547-2024
- FDA event ID
- 94554
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2024
- FDA classified
- 7 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 14 May 2024 | Recall initiated by company | |
| 7 Jun 2024 | Classified by FDA | +24 days |
| 19 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
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
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS III | Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
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