Recalls / Class III
Class IIID-0289-2021
Product
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France 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 10007, exp. date 01/2022
Why it was recalled
Subpotent
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
- 37,400 cartons/60 vials per carton
- Distribution pattern
- Nationwide and Australia
Timeline
- Recall initiated
- 2021-02-22
- FDA classified
- 2021-02-26
- Posted by FDA
- 2021-03-10
- Terminated
- 2022-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0289-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.