RecallDepth
Class II Terminated

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.

Company
Eugia Us Llc
Recall Initiated
February 22, 2024
Posted
March 20, 2024
Recall Number
D-0385-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1160 VIALS
Firm Location
East Windsor, NJ, United States

Reason for Recall

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

Distribution

Nationwide

Lot / Code Info

Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.

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