Recalling firm
Eugia US LLC
Product type
Drug
Status
Terminated
Report date
2024-03-20
Distribution
Nationwide
Firm state
NJ
Product quantity
1160 VIALS
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Code / lot info
Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.