FDA-Drug2021-09-08Class II
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
Akorn, Inc.
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.
Sold states
Nationwide USA and Puerto Rico
Affected count
142,188 tubes
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0786-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief