D-1496-2022 Class II Terminated
FDA drug recall D-1496-2022 was initiated by Akorn, Inc. on Aug 31, 2022 and is designated Class II. Reason for recall: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. The recall status is terminated (terminated Jun 18, 2024). Affected quantity: 48,636 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 14, 2022
- Initiation Date
- Aug 31, 2022
- Termination Date
- Jun 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,636 tubes
Product Description
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Reason for Recall
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Distribution Pattern
USA nationwide
Code Information
Lot#: 9J58A, 9J58B, Exp 8/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1496-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026