Eye Itch Relief — Class II drug recall D-1628-2020
Terminated recall by Akorn, Inc., reported 2020-10-07, distributed nationwide. CGMP Deviations
| Recall number | D-1628-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2020-09-03 |
| Classified | 2020-09-30 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2022-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 25,843 bottles |
| Reason classes | cgmp |
| NDC | 59779-0920-01 |
| Lot numbers | 12/20, 8A11A |
Product
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Reason for recall
CGMP Deviations
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-1628-2020. 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.