The FDA has issued a statement urging healthcare professionals and pharmacists to stop dispensing products made by Cantrell Drug Company to patients.
In a release, the agency said it is “concerned about serious deficiencies in Cantrell’s compounding operations, including its process to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.”
Based in Little Rock, Ark., Cantrell manufactures sterile, injectable drugs, including lidocaine, neostigmine methylsulfate, norepinephrine bitartrate and more. It also produces about 80,000 morphine sulfate syringes each month, which have been placed on the FDA’s drug shortage list.
The company’s CEO blamed the issue on communication, not compliance, and pointed out that several independent experts had deemed its quality control processes sufficient.
Read the full UPI report.