Public recall detail

BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients

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Recall Safety notice
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Quick summary: BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients .

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Recall details

Quick summary: BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients .

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Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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BLINCYTO has recently been authorized with an additional option of preparing a 7-day infusion bag, using bacteriostatic 0.9% sodium chloride containing 0.9% benzyl alcohol as a preservative. Benzyl alcohol has the potential to cause serious and fatal adverse reactions when administered intravenously to neonates and infants. Therefore, 0.9% sodium chloride containing 0.9% benzyl alcohol is not recommended for use in the preparation of BLINCYTO intended to be administered to neonates, infants, or patients weighing less than 22 kg.

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