Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
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 Lack of sterility assurance
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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