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Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 25, 2015.
The practice of using multi-dose insulin pens, meant for single patient use only, among multiple patients has been linked to health care–associated infections. This announcement outlines federal labeling requirements to raise awareness of the risks associated with this practice to prevent misuse of the devices.
Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; May 23, 2012.
This announcement raises awareness of pre-filled medication cartridges that may be overfilled, thereby increasing the risk of overdose. The FDA recommends that practitioners confirm the dosage prior to dispensing and administering the medication.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 10, 2011.
This announcement reveals a labeling change to reduce the potential for misadministration of a pain medication.
MedWatch Safety Alert, FDA Drug Safety Communication. Silver Spring, MD: US Food and Drug Administration; August 2, 2010.
This announcement reports on numerous errors in which an oral medication, nimodipine, was administered intravenously and describes how such errors occur.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 9, 2009.
This alert notifies health care providers of the potential for patient harm if a particular inhalation powder is reconstituted and incorrectly administered.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 25, 2009.
This announcement explains the potential for medication errors due to a discrepancy between dosing instructions and dosing dispenser measurement units for the drug Tamiflu.
FDA Public Health Advisory [US Food and Drug Administration Web site]. March 11, 2008.
This announcement alerts parents and health care professionals about the potentially fatal dangers of Tussionex Pennkinetic Extended-Release Suspension, a prescription cough medicine that should not be used in children younger than 6 years.
FDA Alert [US Food and Drug Administration Web site]. April 25, 2006.
This alert highlights the dangers of administering promethazine hydrochloride to young children and includes information sheets for both patients and health care professionals.