Azelastine HCl Ophthalmic Solution 0 — Class III drug recall D-1168-2018
Terminated recall by Akorn, Inc., reported 2018-09-05, distributed nationwide. Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
| Recall number | D-1168-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-08-08 |
| Classified | 2018-08-29 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 8,574 bottles |
| Reason classes | specification failure |
| NDC | 17478-0718-10 |
| Lot numbers | 6K89A, 6K90A, 6K92A, 9/18 |
Product
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Reason for recall
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
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-1168-2018. 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.