Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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
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.
Reason Failed Stability Specification: Water determination was found not complying with specification.
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Lack of sterility assurance
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.