Sodium Chloride Ophthalmic Ointment USP recall: Sterility Concern
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
Why was Sodium Chloride Ophthalmic Ointment USP recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 9J58A, 9J58B, Exp 8/31/2022
- 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
- Recalling firm
- Akorn, Inc.
- Quantity
- 48,636 tubes
- Distribution
- USA nationwide
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)