Pharmakon Pharmaceuticals has initiated a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, a product whose use has been associated with “serious adverse events in three infants,” according to a statement from the Food and Drug Administration.
The recall began Feb. 11, following laboratory results indicating the product was “super-potent,” according to the statement . “Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death,” the FDA noted.
This batch of the product, sold as 1-mL syringes, was made on Feb. 3 by Pharmakon, in Noblesville, Ind. The drug manufacturer distributed the product to one facility in Indiana and another in Illinois. The recalled product’s expiration date is March 19, 2016, and it is labeled with lot E52418EV11C and NDC 45183-0322-78.
The FDA encourages health care professionals with the recalled product to quarantine it and to report adverse events or side effects related to the product’s use to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. Both health care professionals and patients can complete and submit reports to the program at www.fda.gov/MedWatch/report or call 1-800-332-1088 to request a reporting form.