The Recall Desk
HighFDA (Drugs)·D-0132-2023·Announced 2023-01-25

FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

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: This FDA Class II recall involves a prescription sterile pharmaceutical product with CGMP deviations affecting manufacturing quality and sterility assurance. While no illnesses or deaths have been reported, CGMP violations in sterile eye products represent a high risk of contamination and potential serious eye infections.

Plain-English summary

Akorn, Inc. has recalled 36,025 tubes of AK-POLY-BAC brand Bacitracin and Polymixin B Sulfate Ophthalmic Ointment USP nationwide due to current good manufacturing practice (CGMP) deviations discovered during the manufacturing process.

The affected product is a prescription eye ointment supplied in 3.5 gram (1/8 ounce) tubes. The recall involves Lot 0G87A with an expiration date of June 30, 2023. This is a voluntary recall initiated by the manufacturer.

CGMP deviations in the production of sterile pharmaceutical products raise concerns about whether the product meets required sterility and quality standards. No illnesses or injuries related to use of this product have been reported to the FDA.

Consumers who possess this product should consult their healthcare provider or pharmacist before discontinuing use. Patients should not use the product if the tube or package appears damaged or compromised.

The recalled product

Product
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Medication
Hazard
Affected units
36,025

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 # 0G87A
  • EXP 06/30/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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