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0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

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Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Monday, August 02, 2010

Audience: Neurosurgery, Anesthesia, Risk Manager

ISSUE: FDA reminded healthcare professionals that oral nimodipine capsules should be given only by mouth or through a feeding or nasogastric tube and should never be given by intravenous administration. Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage (ruptured blood vessels in the brain) and is only available as a capsule. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.

BACKGROUND: In 2006, FDA added a Boxed Warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with "Not for IV Use." FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.

RECOMMENDATION: The Drug Safety Communication, link below, provides additional information for Healthcare Professionals, for Patients, and a Data Summary of reported medication errors. FDA will continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summmary, including links to the Drug Safety Communication and current Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220840.htm

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