Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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

Other Tobramycin recalls

See all

Class III · Low risk Ongoing Jul 27, 2023

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921…

Reason Failed Impurities/Degradation Specifications

Alembic Pharmaceuticals, INC. NDC 62332-518-05 D-1086-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0851-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0850-2023

Class II · Moderate risk Terminated Dec 27, 2022

TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence…

Reason Lack of sterility assurance

Sentara Infusion Services D-0317-2023

Class II · Moderate risk Terminated Dec 22, 2022

TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0240-2023