February 2017 FDA Recall Cyclosporine by Amerisource Health Services
D-0490-2017 - Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities

This Class II drug recall was voluntarily initiated by Amerisource Health Services on February 8, 2017 for the product Cyclosporine. The FDA reported the reason for recall as failed impurities/degradations specifications; out of specification results for maximum unknown impurities and total impurities. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0490-2017

Reason for Recall
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Initiated
02-08-2017
Reported
03-08-2017
Quantity
454 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76484
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amerisource Health Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2017
Product Description About Product Description
Full technical description of the product.
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

68084-879-95 Cyclosporine
68084-879-25 Cyclosporine
68084-921-95 Cyclosporine
68084-921-25 Cyclosporine