FDAFDA · Food and drugs·Recall number D-0786-2021
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
Published September 8, 2021 · Recall initiated: August 2, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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