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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Klarity-C (cyclosporine) Ophthalmic Emulsion Recalled for Lack of Sterility

Agency Publication Date: June 8, 2024
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Summary

Imprimis NJOF, LLC is recalling 136,005 units of Klarity-C (cyclosporine) 0.1% Preservative-Free Sterile Ophthalmic Emulsion (5.5mL) because the drug lacks assurance of sterility. This compounded medication was distributed for office use and should be used with caution as it may be contaminated. Patients who have received this medication should contact their doctor or pharmacist immediately for guidance.

Risk

A lack of sterility assurance in an eye medication can lead to serious microbial contamination. Using a contaminated ophthalmic product can cause sight-threatening eye infections.

What You Should Do

  1. This recall affects Klarity-C (cyclosporine) 0.1% Preservative-Free Sterile Ophthalmic Emulsion sold in 5.5mL bottles (NDC 71384-514-05).
  2. Check the packaging for a lot number and expiration date. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion (5.5mL)
Variants: 0.1%, Preservative-Free
Lot Numbers:
23APR005 (Exp. 5/1/2024)
23MAY024 (Exp. 5/15/2024)
23JUN010 (Exp. 5/30/2024)
23JUN016 (Exp. 6/7/2024)
23JUN047 (Exp. 7/4/2024)
23JUL013 (Exp. 7/11/2024)
23JUL029 (Exp. 7/25/2024)
23JUL030 (Exp. 8/1/2024)
23AUG016 (Exp. 8/7/2024)
23AUG042 (Exp. 9/27/2024)
23SEP017 (Exp. 7/13/2024)
23OCT039 (Exp. 8/3/2024)
23NOV022 (Exp. 8/24/2024)
23NOV036 (Exp. 8/29/2024)
23DEC021 (Exp. 10/4/2024)
24JAN018 (Exp. 10/11/2024)
24JAN026 (Exp. 10/24/2024)
24JAN040 (Exp. 11/2/2024)
24FEB021 (Exp. 11/16/2024)
24MAR005 (Exp. 12/12/2024)
NDC:
71384-514-05

Compounded drug. Labelled: NOT FOR RESALE. OFFICE USE ONLY.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94554
Status: Active
Manufacturer: Imprimis NJOF, LLC
Sold By: Healthcare Facilities; Ophthalmology Clinics; Physician Offices
Manufactured In: United States
Units Affected: 136,005 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.