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
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
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 →Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · stability unverified
See all →- HighFluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns
FDA (Drugs) · 2023-06-07
- ModerateAkorn Recalls Cromolyn Sodium Ophthalmic Solution Over Stability Studies
FDA (Drugs) · 2023-06-07
- ModerateFerrous Sulfate Iron Supplement Drops Recalled for Manufacturing Stability Issues
FDA (Drugs) · 2023-06-07
- HighTrihexyphenidyl Hydrochloride Oral Solution Recalled for Unverified Stability
FDA (Drugs) · 2023-06-07
- HighClobetasol Propionate Ointment recalled due to manufacturing compliance failures
FDA (Drugs) · 2023-06-07