Why it was recalled
CGMP Deviations:
Product description
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
Lot numbers, UPCs & expiration codes
Lot: 1B14B, EXP 1/31/2023; 1C49A, 1C49B, 1C70A, EXP 2/28/2023; 1E09A, 1E34A, 1E34B, 1E09B, EXP 4/30/2023; 1F37C, 1F37A, 1F37B, EXP 5/31/2023; 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, EXP 6/30/2023; 1H77B, 1H80A, 1H80B, 1H77A, EXP 7/31/2023; 1J24A, EXP 8/31/2023; 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, EXP 9/30/2023; 1L90B, 1L90A, 1L92B, 1L92A, EXP 10/31/2023; 1M28A, 1M35A, 1M28B, EXP 11/30/2023; 2D20B, EXP 3/31/2024.
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-0139-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 13, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- 36,455 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0139-2023, 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: 1B14B, EXP 1/31/2023; 1C49A, 1C49B, 1C70A, EXP 2/28/2023; 1E09A, 1E34A, 1E34B, 1E09B, EXP 4/30/2023; 1F37C, 1F37A, 1F37B, EXP 5/31/2023; 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, EXP 6/30/2023; 1H77B, 1H80A, 1H80B, 1H77A, EXP 7/31/2023; 1J24A, EXP 8/31/2023; 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, EXP 9/30/2023; 1L90B, 1L90A, 1L92B, 1L92A, EXP 10/31/2023; 1M28A, 1M35A, 1M28B, EXP 11/30/2023; 2D20B, EXP 3/31/2024.
- Postal code
- 60031-5278
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0139-2023
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 36,455 cartons
- Reason for recall
- CGMP Deviations:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 13, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2023