Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance.
Esmolol HCl in all strengths, all doses, and all packaging.
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 Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Lack of Assurance of Sterility
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Reason Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
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