The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0859-2020·Announced 2020-03-04

Akorn Recalls Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

Akorn, Inc. is recalling specific lots of Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown particulate matter inside the tubes.

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 as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The hazard is limited to particulate matter from the tube material.

Plain-English summary

Akorn, Inc. is recalling 720 tubes of Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes (NDC 17478-622-35). The recall is due to the presence of brown spots observed on the inside of the product tubes. These spots were identified as tin with trace copper, which are the base materials of construction for the tube.

The affected lots are 8B66A (Exp. 01/2021), 8C91A (Exp. 02/2021), 8F07A and 8F16A (Exp. 05/2021), and 8F13A (Exp. 07/2021). The product was distributed nationwide within the United States and Puerto Rico.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the source of purchase or the manufacturer.

The recalled product

Product
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
720

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 (9)

  • 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.

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 →

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