Class III · Low risk Ongoing
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only…
Reason Subpotent Drug
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
What was recalled
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-636-2013
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 (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR…
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…
Reason Subpotent: Out of Specification result observed for low assay
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