Recalls / Class III
Class IIID-0859-2020
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
- Affected lot / code info
- 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.
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.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 720 tubes
- Distribution pattern
- Nationwide within United States and Puerto Rico
Timeline
- Recall initiated
- 2020-02-21
- FDA classified
- 2020-02-27
- Posted by FDA
- 2020-03-04
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0859-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.