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FDA Medical Bulletin * June 1996 * Volume 26 Number 2
FDA Medical Bulletin * June 1996 * Volume 26 Number 2
FDA has received reports of several deaths when the wrong concentration (2500 mg/10-mL) of BREVIBLOC (Esmolol Hydrochloride Injection) was administered. Two concentrations are available.
The CONCENTRATE, available in a 10-mL ampule containing 2500 mg (2.5 grams) of Esmolol, is intended for DILUTION ONLY. The product is also available in a 10-mL vial (100 mg) intended for direct bolus injection.
The manufacturer has changed the labeling of the ampule to include a red warning sticker on the neck. As an additional safety measure, we recommend that access to the ampule be restricted to personnel who normally prepare the solutions.
REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088
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