Pharmakon Pharmaceuticals is voluntarily recalling morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use, because the product is super-potent, according to the FDA.
The recalled product was made on Feb. 3, with an expiration date of March 19, and distributed to two medical facilities, one in Indiana and one in Illinois.
On Feb. 16, the FDA was alerted of serious adverse events in three infants associated with the use of the recalled morphine sulfate products from Pharmakon.
It was not clear what exactly the incidents were.
