Akorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities
Akorn, Inc. is recalling specific lots of Azelastine HCl Ophthalmic Solution 0.05% because of out-of-specification results for Azelastine N-oxide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Akorn, Inc. is recalling 8,574 bottles of Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, NDC 17478-718-10. The affected products are identified by Lot numbers 6K89A, 6K90A, and 6K92A, with an expiration date of 9/18. The recall was initiated due to out-of-specification (OOS) results for Azelastine N-oxide, a degradation impurity.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The products were distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected bottles and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- 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, NDC 17478-718-10
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 8,574
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot# 6K89A
- 6K90A
- 6K92A
- exp 9/18
Distribution
Distributed nationwide across the United States.
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