Why it was recalled
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Product description
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
Lot numbers, UPCs & expiration codes
Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
Where it was sold
Distributed Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0475-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2017
- FDA report date
- Mar 1, 2017
- Quantity
- 19,584 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0475-2017, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Terminated
- Country
- Canada
- Event ID
- 76402
- Address
- 150 Signet Dr
- Code information
- Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
- Report date
- Mar 1, 2017
- Product type
- Drugs
- Recall number
- D-0475-2017
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 19,584 bottles
- Termination date
- Jun 15, 2022
- Reason for recall
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide
- Recall initiation date
- Feb 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2017