Antibiotic Injection Recalled for Failed Stability Specification
Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable medication due to failed stability specification. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (3) because it is a risk-of-harm product (injectable drug with stability concerns) where injury has not yet been reported.
Plain-English summary
Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package. The recall was initiated due to a failed stability specification—water determination was found not complying with specification requirements. Lot numbers 3TB23001 and 3TB23002, with an expiration date of 04/30/2025, are affected. The product was distributed nationwide.
Tobramycin is an antibiotic supplied for intravenous use in pharmacy bulk packages. The vials are not for direct infusion. Healthcare providers, pharmacists, and medical facilities should quarantine any remaining stock of the affected lot numbers to prevent further distribution.
Patients who have received Tobramycin from the affected lots should not discontinue treatment without consulting their healthcare provider. Healthcare professionals should consult the FDA recall notice for additional information and instructions on returning or disposing of affected product.
The recalled product
- Product
- TOBRAMYCIN (TOBRAMYCIN)
- Brand
- TOBRAMYCIN
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable Antibiotic
- Affected units
- 1,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: 3TB23001
- 3TB23002
- Exp. 04/30/2025.
UPCs (1)
- 0355150470013
Distribution
Distributed nationwide across the United States.
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