Cequa Solution/ Drops
FDA Recall NDC 47335-507
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Cequa (NDC 47335-507). A significant event, classified as Class III, was initiated on Sep 07, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Subpotent: Out of Specification result observed for low assay"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent: Out of Specification result observed for low assay
Sep 07, 2023
Sep 27, 2023
69,707 cartons
Recall Profile & Regulatory Data
Event ID
93006
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide wide in the USA
Termination Date
Feb 13, 2024
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
Batch or Lot Expiration Information
Lot# 10026, Lot 10027, Exp. 09/2023.
Affected Packages Involved in this Recall
47335-506-96Product
47335-507-97Product
April 2022 Class III Recall: Subpotent Drug and Presence of Particulate Matter
Recall Number
Class III Terminated
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Apr 01, 2022
Apr 13, 2022
73,030 boxes
Recall Profile & Regulatory Data
Event ID
89917
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jul 21, 2023
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
Batch or Lot Expiration Information
Lot# Lot: 10014, 10016, Exp 08/2022
Affected Packages Involved in this Recall
47335-506-96Product
47335-507-97Product
Class III Terminated
Subpotent and Presence of Particulates .
May 07, 2021
May 26, 2021
N/A
Recall Profile & Regulatory Data
Event ID
87922
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Jun 17, 2022
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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Batch or Lot Expiration Information
Lot# 10009, exp. date 03/2022 10006, exp. date 01/2022
Affected Packages Involved in this Recall
47335-506-96Product
47335-507-97Product
Class III Terminated
Subpotent
Feb 22, 2021
Mar 10, 2021
37,400 cartons/60 vials per carton
Recall Profile & Regulatory Data
Event ID
87349
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Australia
Termination Date
Jan 21, 2022
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
Batch or Lot Expiration Information
Lot# Lot 10007, exp. date 01/2022
Affected Packages Involved in this Recall
47335-506-96Product
47335-507-97Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
