Akorn, Inc.: Drug Recall
Recall #D-1496-2022 · 08/31/2022
Class II: Risk
Recall Details
- Recall Number
- D-1496-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Terminated
- Date Initiated
- 08/31/2022
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,636 tubes
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.
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
Distribution Pattern
USA nationwide
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.