Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- August 2, 2021
- Posted
- September 8, 2021
- Recall Number
- D-0786-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 142,188 tubes
- Firm Location
- Lake Forest, IL, United States
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
Nationwide USA and Puerto Rico
Lot / Code Info
Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
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