Akorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities

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

• impurity

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.

Distribution

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