PlainRecordsFDA · Drug recall
Cequa (cyclosporine ophthalmic solution) 0.09%…
- Date
- March 10, 2021
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- 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
- Reason
- Subpotent
- Distribution pattern
- Nationwide and Australia
- Quantity
- 37,400 cartons/60 vials per carton
- Codes and lots
- Lot 10007, exp. date 01/2022
- Recall started
- Feb. 22, 2021
- Recall number
- D-0289-2021
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0289-2021. The agency record governs; check it and the company before acting.