Eugia US LLC: Drug Recall

Recall #D-0385-2024 · 02/22/2024

Class II: Risk

Recall Details

Recall Number: D-0385-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Terminated
Date Initiated: 02/22/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1160 VIALS

Reason for Recall

Failed Stability Specification: Water determination was found not complying with specification.

Product Description

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.

Distribution Pattern

Nationwide

Other Recalls by Eugia US LLC

Class II: Risk 05/29/2025

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/10/2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II: Risk 12/27/2024

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.