Class III · Low risk Ongoing
Klarity-C Drops
Reason Subpotent Drug
Cyclosporine Ophthalmic
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
What was recalled
Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Recalling firm
- Pallimed Solutions
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-864-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cyclosporine recalls
See all
Class II · Moderate risk Ongoing
Klarity-C
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk Terminated
Cequa
Reason Subpotent: Out of Specification result observed for low assay
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