Azelastine HCl Ophthalmic Solution 0.05% recall: Impurity Out of Spec
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Why was Azelastine HCl Ophthalmic Solution 0.05% recalled?
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
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# 6K89A, 6K90A, 6K92A, exp 9/18
- Product
- Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
- Recalling firm
- Akorn, Inc.
- Quantity
- 8,574 bottles
- Distribution
- Nationwide USA
- Recall date
- September 5, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)