Why it was recalled
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Product 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
Lot numbers, UPCs & expiration codes
Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1168-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 8, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 8,574 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1168-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80767
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot# 6K89A, 6K90A, 6K92A, exp 9/18
- Postal code
- 60045-4862
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1168-2018
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 8,574 bottles
- Termination date
- Nov 3, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2018