A voluntary recall of morphine was issued because it was found to be “super-potent” and capable of causing serious injury or death. On February 16, 2016, FDA was alerted of serious adverse events in three babies associated with the use of the recalled morphine sulfate products from Pharmakon.
Pharmakon initiated 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. The company issued the recall on February 11, 2016, after receiving laboratory results showing the product was super-potent, according to an FDA announcement.
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.
The FDA is urging health care professionals to check their medical supplies, quarantine the recalled product from Pharmakon, and not administer them to patients.
The recalled product was made on February 3, 2016, with an expiration date of March 19, 2016, and 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.
Attorneys Fred Pritzker is investigating this recall. If your child has been harmed by this product, please contact Fred for a free consultation. Fred has successfully handled cases just like this. In one case a woman was killed when she was injected with a drug that was 10 times stronger than it should have been. In another case, they represented several families whose babies had been harmed.