FDAFDA · Food and drugs·Recall number D-0475-2017
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
Published March 1, 2017 · Recall initiated: February 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYCLOSPORINE
- Manufacturer
- Apotex Inc.
- Distributor
- Distributed Nationwide
- UPC
- 360505013401
- Lot
- Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.