The FDA 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.
Pharmakon initiated the voluntary recall on February 11 after receiving laboratory results showing the product was super-potent. On February 16, the FDA was alerted of serious adverse events in three infants associated with the use of the recalled morphine sulfate products from Pharmakon.
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.
The recalled product was made on February 3, 2016, with an expiration date of March 19, 2016, and is 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.
The FDA advises health care professionals to immediately check their medical supplies and quarantine the recalled product from Pharmakon.
Source: FDA; February 17, 2016.