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Recall Observatory FDA recall evidence

Drug 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

D-0786-2021

August 02, 2021

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 88594
Status
Terminated
Classification
Class II
Quantity
142,188 tubes
Official record key
drug-enforcement:D-0786-2021

Official wording

Reason: 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.

Code information: Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.