Recalls / Class III
Class IIID-0770-2022
Product
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
- Brand name
- Cequa
- Generic name
- Cyclosporine
- Active ingredient
- Cyclosporine
- Route
- Ophthalmic, Topical
- NDCs
- 47335-506, 47335-507
- FDA application
- NDA210913
- Affected lot / code info
- Lot: 10014, 10016, Exp 08/2022
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.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 73,030 boxes
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-04-01
- FDA classified
- 2022-04-14
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-07-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0770-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.