FDA recall D-0385-2024

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2024-02-22

Report date

2024-03-20

Termination date

2025-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2024