Akorn recalls all Tobramycin Inhalation Solution USP 30:00 mg/5mL ampules due to inability to conduct stability studies after firm went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Tobramycin Inhalation Solution USP 300 mg/5 mL, 4 single-dose ampules because the manufacturer went out of business and can no longer perform stability testing. This means the product may not be safe for use as it could degrade over time.
The manufacturer went out of business and can no longer conduct stability studies, which means the product's effectiveness and safety over time cannot be confirmed. This could lead to degraded medication quality if stored or used beyond the intended timeframe.
Prescription users of Tobramycin Inhalation Solution USP 300 mg/5 mL, 4 single-dose ampules manufactured by Akorn, Inc. in Lake Forest, IL are affected. Healthcare providers and patients using this medication are at risk due to potential stability issues.
Check for Tobramycin Inhalation Solution USP 300 mg/5 mL, 4 single-dose ampules with any NDC number or lot number from the product label. All units produced by Akorn, Inc. in Lake Forest, IL are included in this recall.
Look for the NDC number or lot number on the product label to confirm if it is recalled.
The manufacturer went out of business and can no longer continue stability studies, which means the product's safety and effectiveness over time cannot be confirmed.
The recall record does not specify a remedy, so no action is required beyond checking the product label.
Check the product label for Tobramycin Inhalation Solution USP 300 mg/5 mL, 4 single-dose ampules with any NDC number or lot number from the manufacturer's location in Lake Forest, IL.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0850-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0850-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
