Recalls / Class II
Class IID-0786-2021
Product
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
- Affected lot / code info
- Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
Why it was recalled
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.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 142,188 tubes
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2021-08-02
- FDA classified
- 2021-08-31
- Posted by FDA
- 2021-09-08
- Terminated
- 2022-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0786-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.