Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
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 sterility assurance.
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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