D-0475-2017 Class II Terminated
FDA drug recall D-0475-2017 was initiated by Apotex Inc. on February 3, 2017 and is designated Class II. Reason for recall: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. The recall status is terminated (terminated June 15, 2022). Affected quantity: 19,584 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 1, 2017
- Initiation Date
- February 3, 2017
- Termination Date
- June 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,584 bottles
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
Reason for Recall
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Distribution Pattern
Distributed Nationwide
Code Information
Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401