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FDA Alert: Recall of IV Morphine Made by Pharmakon

February 17, 2016
Pharmakon Pharmaceuticals issues recall after lot of IV morphine found to be "super-potent."

The U.S. Food and Drug Administration is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent, according to an alert.

Pharmakon initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent.

Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death. Health care professionals should immediately check their medical supplies, quarantine the recalled product from Pharmakon, and not administer them to patients.
The recalled product was made on February 3, 2016, with an expiration date of March 19, 2016, and labeled with lot E52418EV11C and NDC 45183-0322-78. The recalled product was distributed to two medical facilities – one in Indiana and one in Illinois.  
On February 16, 2016, FDA was alerted of serious adverse events in three infants associated with the use of the recalled morphine sulfate products from Pharmakon. Patients who have received this drug product and who have concerns should contact their health care professionals.

For more information, please visit: FDA

Last updated on: November 5, 2020
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