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
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
cGMP Deviations