Tobramycin for Injection recall
FDA recall D-0385-2024 · initiated Feb 22, 2024
Eugia US LLC recalled Tobramycin for Injection in Feb 2024 — an FDA Class II recall (D-0385-2024) because Failed Stability Specification: Water determination was found not complying with specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specification: Water determination was found not complying with specification.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1160 VIALS
Details
- Product
- Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Feb 22, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Tobramycin for Injection recalled?
- Eugia US LLC recalled Tobramycin for Injection in Feb 2024 — an FDA Class II recall (D-0385-2024) because Failed Stability Specification: Water determination was found not complying with specification. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tobramycin for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0385-2024 was: Failed Stability Specification: Water determination was found not complying with specification.
- Is a recalled Tobramycin for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tobramycin for Injection are affected?
- Distributed: Nationwide. The recall covers these lots — Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0385-2024.