Artificial Tears Ointment recall: Sterility Concern
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…
Why was Artificial Tears Ointment recalled?
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.
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 #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
- 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…
- Recalling firm
- Akorn, Inc.
- Quantity
- 142,188 tubes
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)