Class II · Moderate risk Terminated
Esmolol HCl 100 mg/10 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Esmolol HCl in all strengths
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Esmolol HCl in all strengths, all doses, and all packaging.
- Recalling firm
- Pharmedium Services, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0464-2018
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 Esmolol recalls
See all
Class II · Moderate risk Terminated
Esmolol HCl Injectable Solution 100 mg/10 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Esmolol HCl all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Brevibloc DOUBLE STRENGTH Premixed Injection
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Class II · Moderate risk Terminated
Brevibloc Premixed Injection
Reason Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
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