Recalls / Class III
Class IIID-0391-2021
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 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 # 10009, exp. date 03/2022 10006, exp. date 01/2022
Why it was recalled
Subpotent and Presence of Particulates .
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-05-07
- FDA classified
- 2021-05-20
- Posted by FDA
- 2021-05-26
- Terminated
- 2022-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0391-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.