Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter
Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Akorn, Inc. is voluntarily recalling 24 tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes (NDC 0363-9050-00). The recall is limited to Lot #8G59A with an expiration date of 06/2021. The product was distributed nationwide within the United States and Puerto Rico by Walgreen Co.
The recall was initiated because brown spots were observed on the inside of the product tubes. These spots were identified as tin with trace copper, which are the base of the materials of construction for the tube. This indicates the presence of particulate matter in the ophthalmic ointment.
Consumers who have this specific product should stop using it and contact their pharmacist or Akorn, Inc. for further instructions. The FDA has classified this recall as Class III, which means the product is not likely to cause adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #:8G59A
- Exp. Date 06/2021
Distribution
Part of a larger recall action
This product is one of 3 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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