Class II · Moderate risk Terminated
Tobramycin for Injection
Reason Failed Stability Specification: Water determination was found not complying with specification.
Tobramycin 300 mg/7.5 mL Syringe
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
What was recalled
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1471-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tobramycin recalls
See all
Class III · Low risk Ongoing
Tobramycin Opthalmic Solution USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Tobramycin Inhalation Solution USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Tobramycin 660mg in Ns 66ml
Reason Lack of sterility assurance
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