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.
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 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
- stability-unverified
- 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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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