Akorn, Inc.: Drug Recall
Recall #D-0786-2021 · 08/02/2021
Class II: Risk
Recall Details
- Recall Number
- D-0786-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Terminated
- Date Initiated
- 08/02/2021
- Location
- Lake Forest, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142,188 tubes
Reason for Recall
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Product Description
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
Distribution Pattern
Nationwide USA and Puerto Rico
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.