The Recall Desk
HighFDA (Drugs)·D-1496-2022·Announced 2022-09-14

Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns

Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a sterile ophthalmic product with turbidity indicating potential contamination. While no illnesses or injuries have been reported, this product poses a risk of harm to the eye if contaminated, meeting the criterion for High severity.

Plain-English summary

Akorn, Inc. is recalling 48,636 tubes of Sodium Chloride Ophthalmic Ointment USP, 5%, a sterile ointment used for eye care. The recalled product comes in 3.5-gram tubes with lot numbers 9J58A and 9J58B, with an expiration date of August 31, 2022. The product was manufactured at Akorn, Inc.'s facility in Lake Forest, Illinois and distributed nationwide throughout the United States.

The recall was initiated because turbidity (cloudiness) was discovered in samples of Sodium Chloride Ophthalmic Ointment during sterility testing. Turbidity in a sterile ophthalmic product indicates potential contamination or failure to meet sterility requirements. The FDA has determined this represents a Class II recall, and the scope has been expanded to include additional lots and other products that may share the same manufacturing root cause.

Consumers who have this product should stop using it immediately. If you have used this ointment and experience any eye irritation, redness, discharge, or other unusual symptoms, contact your healthcare provider or seek medical attention. Pharmacies and healthcare facilities that dispensed this product should remove it from inventory and return it to Akorn, Inc. for a refund.

The recalled product

Product
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Care
Hazard
  • turbidity
  • contamination
  • sterility-failure

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 (3)

  • Lot#: 9J58A
  • 9J58B
  • Exp 8/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category