Eugia US LLC recalls Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package for potential stability issues. This product was manufactured in India and distributed to US pharmacies. Check your carton NDC 55150-470-06 and vial NDC 55150-470-01 for affected lots.
Failed Stability Specification: Water determination was found not complying with specification.
Eugia US LLC is recalling Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package because it failed stability tests. This means the product may not be safe for intravenous use as it could degrade over time.
The product failed stability testing, meaning it may degrade over time. This could potentially affect the effectiveness or safety of the medication when used for intravenous treatment. However, the product is not intended for direct patient use and is only for pharmacy bulk packaging.
Pharmacists and healthcare facilities that received this specific Tobramycin injection product. The risk is low as it's a pharmacy bulk package not intended for direct patient use.
Check for carton NDC 55150-470-06 and vial NDC 55150-470-01. The affected lots are 3TB23001 and 3TB23002, expiring April 30, 2025.
Look for carton NDC 55150-470-06 and vial NDC 55150-470-01 on the packaging.
The product was recalled due to stability issues, but it is not intended for direct patient use. Healthcare facilities should follow the recall instructions.
The recall record does not specify a remedy, so contact Eugia US LLC for further instructions.
The product was manufactured in India and distributed to US pharmacies with specific lot numbers and expiration date of April 30, 2025.
We’ve drafted a message you can send Eugia to request your refund or repair — edit it as you like.
Subject: Recall D-0385-2024 — Eugia Eugia Hello, I own a Eugia that is covered by recall D-0385-2024 from Eugia. 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.
