Class III · Low risk
Klarity-C Drops
Subpotent Drug
Cequa (cyclosporine ophthalmic solution)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
Affected NDC
47335-0506-96
Compare with the code on your package — it is the most precise check available.
Drug: Cyclosporine Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cequa cyclosporine NDC 47335-0506 |
.0009 g/mL | Solution/ Drops Ophthalmic|topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 47335-506-96
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0770-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cyclosporine recalls
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Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Other recalls by Sun Pharmaceutical Industries INC
All 2022 recalls
Unclassified
Nystatin Cream
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Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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