Super Potent Morphine Sulfate Recalled

Pharmakon Pharmaceuticals has issued a voluntary recall of a morphine product that is super potent.

The recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, began on February 11, 2016, after laboratory reports revealed the excessive potency of the product.

However, the manufacturing company learned of adverse effects on February 16, 2016, following a report of 3 events associated with infants and the use of the recalled products.

“Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death,” the FDA stated in its press release.

Pharmacists should check their supplies, quarantine the product, and stop administering the injection to patients.

The recalled product was initially manufactured on February 3, 2016, and it has an expiration date of March 19, 2016. It is labeled with lots E52418EV11C and NDC 45183-0322-78.

The products were distributed to 2 medical facilities—one in Illinois and one in Indiana.

Health care professionals should report any adverse effects to the MedWatch Adverse Event Reporting Program.

Back in May 2015, Pharmakon Pharmaceuticals received a warning letter from the FDA following some 2014 inspections. Investigators told the president of Pharmakon that they found “serious deficiencies” in the company’s practices for producing sterile drug products.

“Your products may be produced in an environment that poses a significant contamination risk,” the FDA wrote in its letter.