The Food and Drug Administration (FDA) is warning of a voluntary recall of Pharmakon Pharmaceuticals’ Morphine Sulfate 0.5mg/mL preservative-free in 0.9% Sodium Chloride, 1mL syringe, for intravenous use due to super-potency.
Pharmakon initiated the recall on February 11, 2016 following laboratory results that showed the product was super-potent. Five days later, the FDA was informed of serious adverse events in 3 infants related to the use of the recalled Morphine Sulfate products.
The affected products have Lot #E52418EV11C, NDC 45183-0322-78 with an expiration date of March 19, 2016. They were distributed to medical facilities in Indiana and Illinois. Administering super-potent morphine to a patient may result in serious consequences including respiratory depression, coma, and death.
In May 2015, Pharmakon was issued a warning letter from the FDA in May 2015 regarding deficiencies found in facility inspections.
Morphine Sulfate is a CII controlled substance indicated for pain management.
For more information call (888) 463-6332 or visit FDA.gov.