FDA Drug recall D-1168-2018
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,…
- FDA Drug
- Class III
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class III recall of 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,… by Akorn, citing failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1168-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-08 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Identifiers
| code_info | Lot# 6K89A, 6K90A, 6K92A, exp 9/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1168-2018%22
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