Class III · Low risk
Tobramycin Opthalmic Solution USP
Failed Impurities/Degradation Specifications
Tobramycin for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specification: Water determination was found not complying with specification.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDCs
55150-0470-01
55150-0470-06
Compare with the code on your package — it is the most precise check available.
Drug: Tobramycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tobramycin NDC 55150-0470 |
SULFATE 1.2 g/30mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Eugia US LLC | Rx |
- Recalling firm
- Eugia US LLC
- NDC code
- 55150-470-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0385-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tobramycin recalls
See all
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin Inhalation Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin 660mg in Ns 66ml
Lack of sterility assurance
Class II · Moderate risk
Tobramycin Fortified 15mg/Ml Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Eugia US LLC
All 2024 recalls
Class III · Low risk
Lidocaine HCl Injection
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk
Tirofiban Hydrochloride Injection 12.5 mg/250 mL
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk
Tirofiban Hydrochloride Injection 5 mg/100 mL
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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