Difluprednate Emulsion
FDA Recall NDC 69097-341
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Difluprednate (NDC 69097-341). A significant event, classified as Class II, was initiated on Aug 22, 2022 by Cipla Usa Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility."
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 II Terminated
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Aug 22, 2022
Sep 14, 2022
117,844 bottles
Recall Profile & Regulatory Data
Event ID
90796
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 27, 2023
Product Description
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Batch or Lot Expiration Information
Lot# : DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023
Affected Packages Involved in this Recall
69097-341-35Product
Class II Terminated
Lack of Assurance of Sterility: Complaints received of defective container closure.
Aug 02, 2022
Aug 17, 2022
7,992 bottles
Recall Profile & Regulatory Data
Event ID
90702
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 27, 2023
Product Description
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Batch or Lot Expiration Information
Lot# DEG3LC2, Exp 05/2023
Affected Packages Involved in this Recall
69097-341-35Product
Class II Terminated
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Jul 14, 2022
Jul 27, 2022
8,136 bottles
Recall Profile & Regulatory Data
Event ID
90608
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 27, 2023
Product Description
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.
Batch or Lot Expiration Information
Batch# DEG4LC2, exp. date 05/2023
Affected Packages Involved in this Recall
69097-341-35Product
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.
