D-1168-2018 Class III Terminated
FDA drug recall D-1168-2018 was initiated by Akorn, Inc. on Aug 8, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide The recall status is terminated (terminated Nov 3, 2020). Affected quantity: 8,574 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 8, 2018
- Termination Date
- Nov 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,574 bottles
Product Description
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
Distribution Pattern
Nationwide USA
Code Information
Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1168-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026