Drug 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
D-0475-2017
Product summary
- Firm
- Apotex Inc.
- Event
- Event 76402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,584 bottles
- Official record key
drug-enforcement:D-0475-2017
Official wording
Reason: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Code information: Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Potency or specification failure
out of specification