Cyclosporine 1% Opth Sol — Class II drug recall D-0401-2016
Terminated recall by Western Drug, reported 2015-12-09, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0401-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Western Drug, Springerville, AZ, United States |
| Recall initiated | 2015-10-19 |
| Classified | 2015-12-01 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 4 containers |
| Reason classes | sterility |
Product
Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Reason for recall
Lack of Assurance of Sterility
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-0401-2016. 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.