🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: August 8, 2018 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# 6K89A, 6K90A, 6K92A, exp 9/18
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn, Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot# 6K89A, 6K90A, 6K92A, exp 9/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1168-2018

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