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.
Reported: March 20, 2024 Initiated: February 22, 2024 #D-0385-2024
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.
Reason for Recall
Failed Stability Specification: Water determination was found not complying with specification.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 1160 VIALS
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Eugia US LLC. Units affected: 1160 VIALS.
Why was this product recalled? ▼
Failed Stability Specification: Water determination was found not complying with specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0385-2024.
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