Skip to content
Recall Observatory FDA recall evidence

Drug product

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

D-1496-2022

August 31, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90813
Status
Terminated
Classification
Class II
Quantity
48,636 tubes
Official record key
drug-enforcement:D-1496-2022

Official wording

Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Code information: Lot#: 9J58A, 9J58B, Exp 8/31/2022

Distribution pattern: USA nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations