Recalls / Class II
Class IID-0475-2017
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
- Brand name
- Cyclosporine
- Generic name
- Cyclosporine
- Active ingredient
- Cyclosporine
- Route
- Oral
- NDCs
- 60505-0133, 60505-0134
- FDA application
- ANDA065040
- Affected lot / code info
- Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
Why it was recalled
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Recalling firm
- Firm
- Apotex Inc.
- Manufacturer
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Dr, N/A, North York, N/A N/A, Canada
Distribution
- Quantity
- 19,584 bottles
- Distribution pattern
- Distributed Nationwide
Timeline
- Recall initiated
- 2017-02-03
- FDA classified
- 2017-02-23
- Posted by FDA
- 2017-03-01
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0475-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.