Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
FDA recall notice · announced March 4, 2020 · Akorn
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The product
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
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.
Notes
Distribution: Nationwide within United States and Puerto Rico
Lot/code information: Lot #:8G59A, Exp. Date 06/2021
Quantity: 24 tubes
Status: Terminated
Products in this recall event:
- CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01 (D-0861-2020)
- Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35 (D-0859-2020)
- Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00. (D-0860-2020)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.