Drug Enforcement D-0385-2024

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

Status

Completed

Classification

Class II

Report Date

March 20, 2024

Termination Date

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Product Information

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.
Product quantity
1160 VIALS
Reason for recall
Failed Stability Specification: Water determination was found not complying with specification.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0385-2024
Event ID
94081
Recall initiation date
February 22, 2024
Center classification date
March 14, 2024
Code info
Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
More code info
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