Cyclosporine Capsule, Gelatin Coated
FDA Recall NDC 68084-921
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 68084-921). A significant event, classified as Class II, was initiated on Feb 08, 2017 by American Health Packaging. 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 08, 2017
Mar 08, 2017
454 cartons
Recall Profile & Regulatory Data
Event ID
76484
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 17, 2017
Product Description
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Batch or Lot Expiration Information
Lot# Lot 154527, exp 4/30/2017
Affected Packages Involved in this Recall
68084-879-95Product
68084-879-25Product
68084-921-95Product
68084-921-25Product
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.
