The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0788-2023·Announced 2023-06-07

AK-POLY-BAC Ophthalmic Ointment Recall for Manufacturing Compliance Deviations

Akorn, Inc. recalls all lots of AK-POLY-BAC ophthalmic ointment nationwide because the company ceased operations and could not complete required stability testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary due to the manufacturer's inability to complete required stability studies, not due to confirmed contamination or harm.

Plain-English summary

AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, manufactured by Akorn, Inc., is being recalled. The product is a sterile, prescription ointment for topical ophthalmic use. All lots and all NDC codes are affected.

The FDA has issued a recall due to current good manufacturing practice (CGMP) deviations. The manufacturer went out of business and could no longer complete the stability studies required to verify that the product maintained its sterility and potency throughout its shelf life.

The affected product was distributed nationwide in the United States and Puerto Rico.

Patients currently using this medication should contact their healthcare provider for guidance. Healthcare providers and pharmacies should discontinue dispensing AK-POLY-BAC and should inform patients who received this product of the recall.

The recalled product

Product
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Antibiotic
Hazard

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 (1)

  • All Lots

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 86 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 86 products in this recall →

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