CycloSPORINE Capsules — Class II drug recall D-0475-2017
Terminated recall by Apotex Inc., reported 2017-03-01, distributed nationwide. Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and
| Recall number | D-0475-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, N/A, Canada |
| Recall initiated | 2017-02-03 |
| Classified | 2017-02-23 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 19,584 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00360505013401 |
| NDC | 60505-0133, 60505-0133-00, 60505-0133-01, 60505-0133-02, 60505-0134, 60505-0134-00, 60505-0134-01, 60505-0134-02 |
| Lot numbers | MJ9837 |
| Expiration dates | 2017-07 |
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
Reason for recall
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0475-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.