D-0770-2022 Class III Terminated
FDA drug recall D-0770-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Apr 1, 2022 and is designated Class III. Reason for recall: Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. The recall status is terminated (terminated Jul 21, 2023). Affected quantity: 73,030 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 13, 2022
- Initiation Date
- Apr 1, 2022
- Termination Date
- Jul 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,030 boxes
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
Reason for Recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 10014, 10016, Exp 08/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0770-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026