A nationwide recall has been issued for a batch of morphine sulfate injection due to a labeling mix-up that could cause patients to receive a different opioid medication, which may pose a risk of fatal overdose.
The agency said some syringes that were labeled as morphine 2 mg/1 ml may instead contain 0.5 mg/0.5 ml of Dilaudid, the brand name for hydromorphone.
Morphine and hydromorphone are both types of opioid medications that are commonly prescribed to patients to manage pain. The former is naturally derived from the opium poppy plant, while the latter is a semi-synthetic opioid made from morphine.
Hydromorphone is the stronger of the two opioid drugs. Its potency is estimated to be about five to seven times greater than morphine on a milligram-for-milligram basis, depending on how it's administered, among other factors.
Fresenius Kabi said the mislabeled single-dose morphine syringes have "a reasonable probability" of causing serious health issues, including life-threatening breathing problems and death.
"Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants," the company added.
No adverse health issues have been reported to date in connection with the recalled batch, which features the lot number 6402820 and an expiration date of December 2028.
The batch was sent to distributors and wholesalers across the country. Fresenius Kabi said it has begun notifying customers and others who may have received the affected product and is arranging returns.
"If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi," the company added. "Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall."
Anyone who has questions about the recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 during normal business hours. The company also advised patients to reach out to their physician or health care provider if they begin experiencing any problems that may be related to receiving the recalled product.
Any adverse reactions and quality concerns stemming from use of the affected syringes can also be reported to the Fresenius Kabi Medical Affairs or Vigilance departments or the FDA's MedWatch Adverse Event Reporting program.