Cornea Coat — Class II drug recall D-1056-2014
Terminated recall by Insight Instruments, Inc., reported 2014-02-12, distributed nationwide. Marketed without an Approved NDA/ANDA.
| Recall number | D-1056-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insight Instruments, Inc., Stuart, FL, United States |
| Recall initiated | 2013-04-24 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2017-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 316,464 kits |
| Reason classes | unapproved product |
Product
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
Reason for recall
Marketed without an Approved NDA/ANDA.
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-1056-2014. 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.