D-0786-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 8, 2021
- Initiation Date
- August 2, 2021
- Termination Date
- August 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142,188 tubes
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
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.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022