Why it was recalled
Subpotent: Out of Specification result observed for low assay
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 10026, Lot 10027, Exp. 09/2023.
Where it was sold
Nationwide wide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1172-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 7, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 69,707 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1172-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93006
- Address
- 2 Independence Way
- Code information
- Lot# 10026, Lot 10027, Exp. 09/2023.
- Postal code
- 08540-6620
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1172-2023
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 69,707 cartons
- Termination date
- Feb 13, 2024
- Reason for recall
- Subpotent: Out of Specification result observed for low assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide wide in the USA
- Recall initiation date
- Sep 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2023