The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0831-2023·Announced 2023-06-07

Neomycin and Polymyxin B Eye Ointment Recalled for Incomplete Stability Studies

Akorn, Inc. has recalled all lots of Neomycin & Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment due to inability to complete required stability studies following the firm's business closure.

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 3/5 (High).

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 is a risk-of-harm product (prescription eye medication) where an unresolved safety concern exists—inability to verify product stability throughout shelf life—yet no injuries have been reported. This fits the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Akorn, Inc. is recalling all lots of Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment supplied in 3.5 gram tubes. This is a prescription eye ointment.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and was unable to continue the stability studies required to verify that the product remains safe and effective throughout its shelf life.

The affected product was distributed nationwide in the United States and Puerto Rico. Patients currently using this medication should consult with their healthcare provider or pharmacist regarding their prescription.

The recalled product

Product
Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
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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