FDA Drug recall D-0490-2017
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC…
- FDA Drug
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC… by Amerisource Health Services, 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-0490-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-08 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Reason
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Identifiers
| ndc | 68084-879-95 |
|---|---|
| ndc | 68084-879-25 |
| ndc | 68084-921-95 |
| ndc | 68084-921-25 |
| code_info | Lot 154527, exp 4/30/2017 |
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-0490-2017%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.