FDA Drug recall D-0475-2017
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apot…
- FDA Drug
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apot… by Apotex, citing failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0475-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-03 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
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
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Identifiers
| upc | 360505013401 |
|---|---|
| ndc | 60505-0133-0 |
| ndc | 60505-0133-2 |
| ndc | 60505-0133-1 |
| ndc | 60505-0134-0 |
| ndc | 60505-0134-2 |
| ndc | 60505-0134-1 |
| ndc | 3605050134 |
| code_info | Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0475-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.