Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection, USP (1.2 grams per Pharmacy Bulk Package). The recall was initiated because testing showed that the moisture levels in the medication did not comply with required stability specifications over time. The affected products include lot numbers 3TB23001 and 3TB23002 with an expiration date of April 30, 2025.
Failure to meet water determination specifications can lead to chemical instability or changes in the medication's potency. This may potentially impact the effectiveness of the drug for patients receiving intravenous treatment.
Firm initiated recall via letter notification.
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION. Manufactured in India for Eugia US LLC.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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