February 2017 FDA Recall Cyclosporine by Apotex Inc.
D-0475-2017 - Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

This Class II drug recall was voluntarily initiated by Apotex Inc. on February 3, 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-0475-2017

Reason for Recall
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Initiated
02-03-2017
Reported
03-01-2017
Quantity
19,584 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76402
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.
Apotex Inc.
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.
Distributed Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-15-2022
Product Description About Product Description
Full technical description of the product.
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

60505-0133-0 Cyclosporine
60505-0133-2 Cyclosporine
60505-0133-1 Cyclosporine
60505-0134-0 Cyclosporine
60505-0134-2 Cyclosporine
60505-0134-1 Cyclosporine