Why it was recalled
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Product description
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Lot numbers, UPCs & expiration codes
Lot #: 8B66A, Exp. Date 01/2021; Lot 8C91A, Exp. Date 02/2021; Lots 8F07A, 8F16A, Exp. Date 05/2021; Lot 8F13A, Exp. Date 07/2021.
Where it was sold
Nationwide within United States and Puerto Rico
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-0859-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 21, 2020
- FDA report date
- Mar 4, 2020
- Quantity
- 720 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0859-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85018
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 8B66A, Exp. Date 01/2021; Lot 8C91A, Exp. Date 02/2021; Lots 8F07A, 8F16A, Exp. Date 05/2021; Lot 8F13A, Exp. Date 07/2021.
- Postal code
- 60045-4862
- Report date
- Mar 4, 2020
- Product type
- Drugs
- Recall number
- D-0859-2020
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 720 tubes
- Termination date
- Jul 28, 2022
- Reason for recall
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
- Distribution pattern
- Nationwide within United States and Puerto Rico
- Recall initiation date
- Feb 21, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2020