Why it was recalled
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Product description
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
Lot numbers, UPCs & expiration codes
Lot: 10014, 10016, Exp 08/2022
Where it was sold
Nationwide 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-0770-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 1, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 73,030 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0770-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89917
- Address
- 2 Independence Way
- Code information
- Lot: 10014, 10016, Exp 08/2022
- Postal code
- 08540-6620
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0770-2022
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 73,030 boxes
- Termination date
- Jul 21, 2023
- Reason for recall
- Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 1, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2022