D-0475-2017 Class II Terminated
FDA drug recall D-0475-2017 was initiated by Apotex Inc. on Feb 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 Jun 15, 2022). Affected quantity: 19,584 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 1, 2017
- Initiation Date
- Feb 3, 2017
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0475-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026