Reported Sep 8, 2021 · Terminated
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn,…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile
- Manufactured byAkorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
- Lot codes and dates
Lot #: 9G01AExp 06/20229H32AExp 07/20229K82A9K82BExp 09/2022
- Amount recalled
- 142,188 tubes
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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