Why it was recalled
CGMP Deviations:
Product description
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Lot numbers, UPCs & expiration codes
Lot # 1F43A, EXP 5/31/2/023
Where it was sold
Nationwide in the 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-0142-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 13, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- 3108 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0142-2023, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 90948
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- Lot # 1F43A, EXP 5/31/2/023
- Postal code
- 60031-5278
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0142-2023
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 3108 bottles
- Reason for recall
- CGMP Deviations:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 13, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2023