CLASS II Drug recall · Reported 20 Mar 2024 · FDA Enforcement Report
Tobramycin for Injection, USP per Pharmacy recalled by Eugia US
Eugia US is recalling Tobramycin for Injection, USP per Pharmacy, distributed nationwide in the US. The recall was initiated on 22 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0385-2024
- FDA event ID
- 94081
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Tobramycin
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Feb 2024
- FDA classified
- 14 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Feb 2024 | Recall initiated by company | |
| 14 Mar 2024 | Classified by FDA | +21 days |
| 20 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specification: Water determination was found not complying with specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specification: Water determination was found not complying with specification.
Which lots are affected?
Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eugia US
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 12.5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
Other Tobramycin recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin Inhalation Solution USP, 300 mg/-dose ampules recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin 660MG IN NS, antibiotic recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Tobramycin Ophthalmic Solution, USP, 0.3% per dropper recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |