Recalls / Class III
Class IIID-1172-2023
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# 10026, Lot 10027, Exp. 09/2023.
Why it was recalled
Subpotent: Out of Specification result observed for low assay
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
- 69,707 cartons
- Distribution pattern
- Nationwide wide in the USA
Timeline
- Recall initiated
- 2023-09-07
- FDA classified
- 2023-09-20
- Posted by FDA
- 2023-09-27
- Terminated
- 2024-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1172-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.