FDA alerts providers to lack of sterility in NuVision Pharmacy products
The Food and Drug Administration expanded an alert about NuVision Pharmacy of Dallas, TX, on Saturday. It said investigators found poor sterile production practices that raised concern about a lack of sterility assurance for the company's sterile drug products.
NuVision recalled methylcobalamin injection (a form of Vitamin B12 injection) and lyophilized injection (freeze-dried powder) products in April because of a lack of sterility assurance and problems with quality control processes. Microbial contamination in a drug product can put a patient or resident at a serious infection risk, the FDA said.
Healthcare providers should check their medical supplies for NuVision sterile products, quarantine them and not give them to patients or residents, the FDA warned. Providers and consumers should report adverse reactions or problems to MedWatch.