FDA announces recall of morphine sulfate products

The U.S. Food and Drug Administration (FDA) has put out an alert to health care professionals about the recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride.

The voluntary recall was issued due to the extremely high potency of the product, which is manufactured and distributed by Pharmakon Pharmaceuticals in Noblesville, Indiana.

The highly potent morphine when injected into patients could cause severe consequences such as respiratory depression, coma and even death. Health care professionals have been advised by the FDA to check their medical supplies immediately to see if they have the product in stock. If they do, they should quarantine the product and cease with the administration of it to their patients.

The recall was initiated when the FDA was alerted to three serious incidents involving infants that were associated with the use of morphine sulfate produced and distributed by Pharmakon. The FDA has continued to encourage health care professionals to report any incidents involving morphine sulfate products to the FDA’s MedWatch Adverse Event Reporting programs.