FDA Recall D-0547-2024
Imprimis NJOF, LLC · Ledgewood, NJ
Class II Ongoing 730 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0547-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- US Nationwide
- Recall initiated
- 2024-05-14
- Classified by FDA Center
- 2024-06-07
- FDA published
- 2024-06-19
- Recalling firm
- Imprimis NJOF, LLC
- Firm location
- Ledgewood, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.