The Recall Desk
ModerateFDA (Drugs)·D-0155-2023·Announced 2023-01-25

Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations

Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary FDA Class II recall for manufacturing quality deviations without reported illnesses, injuries, or specified safety hazards. It fits the rubric category of voluntary precautionary recalls, classified as Moderate.

Plain-English summary

Akorn, Inc. has voluntarily initiated a recall of Sodium Chloride Ophthalmic Ointment, USP 5% (3.5 g per tube) due to deviations from Current Good Manufacturing Practice standards. The recalled product has a National Drug Code (NDC) of 17478-622-35 and was manufactured by Akorn, Inc. in Lake Forest, Illinois.

Approximately 524,506 tubes have been distributed nationwide in the United States. The recalled lot numbers and expiration dates are: 0F69A (5/31/2023); 0G92B, 0G92A (6/30/2023); 0J69A (8/31/2023); 0K29A, 0K24A (9/30/2023); 0M93A, 0M92A, 0M92B (11/30/2023); 1B25A (1/31/2024); 1C74A, 1C77A (2/29/2024); 1E19A (4/30/2024).

Consumers who have purchased this product should stop using it immediately and consult with their healthcare provider. The product should be returned to the point of purchase or contact the manufacturer for instructions on proper disposal or return.

The recalled product

Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • cgmp-deviation

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 (20)

  • Lot: 0F69A
  • EXP 5/31/2023
  • 0G92B
  • 0G92A
  • EXP 6/30/2023
  • 0J69A
  • EXP 8/31/2023
  • 0K29A
  • 0K24A
  • EXP 9/30/2023
  • 0M93A
  • 0M92A
  • 0M92B
  • EXP 11/30/2023
  • 1B25A
  • EXP 1/31/2024
  • 1C74A
  • EXP 2/29/2024
  • 1E19A
  • EXP 4/30/2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same category