CycloSPORINE Capsules recall: Impurity Out of Spec
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp.…
Why was CycloSPORINE Capsules recalled?
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
- Product
- CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp.…
- Recalling firm
- Apotex Inc.
- Quantity
- 19,584 bottles
- Distribution
- Distributed Nationwide
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)