Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Reported: March 4, 2020 Initiated: February 21, 2020 #D-0859-2020
Product Description
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 720 tubes
- Distribution
- Nationwide within United States and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35. Recalled by Akorn, Inc.. Units affected: 720 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 4, 2020. Severity: Low. Recall number: D-0859-2020.
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