Akorn, Inc.: Drug Recall
Recall #D-1495-2022 · 08/31/2022
Class II: Risk
Recall Details
- Recall Number
- D-1495-2022
- 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
- 82,689 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
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
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.