The Recall Desk
LowFDA (Drugs)·D-0860-2020·Announced 2020-03-04

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.

What this means for you

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · particulate matter

See all →