Cyclosporine Capsule, Gelatin Coated
FDA Recall NDC 60505-0134
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cyclosporine (NDC 60505-0134). A significant event, classified as Class II, was initiated on Feb 03, 2017 by Apotex Corp.. The reported reason for this action was: "Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities."
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
February 2017 Class II Recall: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Recall Number
Class II Terminated
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Feb 03, 2017
Mar 01, 2017
19,584 bottles
Recall Profile & Regulatory Data
Event ID
76402
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide
Termination Date
Jun 15, 2022
Product Description
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Batch or Lot Expiration Information
Lot# Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
Affected Packages Involved in this Recall
60505-0133-0Product
60505-0133-2Product
60505-0133-1Product
60505-0134-0Product
60505-0134-2Product
60505-0134-1Product
3605050134Product
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.
