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FDA Announces Injectable Opioid Recall

The Food and Drug Administration (FDA) on March 5 alerted health care providers to a recall of three lots of Hydromorphone HCl, an injectable opioid medication, due to broken and cracked glass vials.

Hydromorphone HCl is an opioid agonist used to manage severe pain. Cracked vials could compromise the product’s sterility, leading to potential injuries for providers and bloodstream infections in patients.

The recalled products, delivered between October 2016 and July 2017, include vials distributed by Hospira with lot number 71330DD and vials distributed by Teva with lot numbers 691853F and 700753F. Health care professionals should discontinue use and quarantine these products.

FDA advises providers to report adverse reactions or quality problems associated with the affected products to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a communications associate for America's Essential Hospitals.