Tobramycin Inhalation Solution Recalled Due to Incomplete Stability Studies
All lots of Tobramycin Inhalation Solution manufactured by Akorn, Inc. have been recalled nationwide due to CGMP deviations. The manufacturer was unable to complete required stability studies before ceasing operations.
What this means for you
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 FDA Class II recall stems from CGMP deviations and the manufacturer's inability to complete required stability studies. No illnesses or injuries are reported, and the hazard is regulatory and process-based rather than a confirmed product defect or contamination.
Plain-English summary
Akorn, Inc. has recalled all lots of Tobramycin Inhalation Solution USP (300 mg/5 mL in 4 single-dose ampules) distributed nationwide in the USA and Puerto Rico. This is a prescription inhalation solution used to treat bacterial respiratory infections.
The recall was issued due to current good manufacturing practice (CGMP) deviations. The manufacturer was unable to continue and complete stability studies required to demonstrate that the drug remains safe and effective throughout its shelf life after the firm went out of business.
Patients currently using this medication should contact their healthcare provider or pharmacist immediately for guidance. Do not stop using the medication without medical advice, as this could compromise treatment for bacterial respiratory infections. Healthcare providers can recommend alternative treatment options or guidance on safe use.
Healthcare providers and pharmacies should quarantine remaining inventory and follow FDA instructions for returning recalled product to the manufacturer or an authorized disposal facility.
The recalled product
- Product
- Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Inhalation solution
- 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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