The FDA is alerting healthcare providers of concerns about a lack of sterility assurance for all drug products made and distributed by NuVision Pharmacy of Dallas, TX. This alert is based on a recent inspection of the facility at which FDA investigators observed poor sterile production practices that raised concerns about a lack of sterility assurance.
In April 2013, NuVision recalled Methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and quality control process concerns. The FDA had received reports of fever, flu-like symptoms, and soreness at the injection site associated with the recalled Methylcobalamin injection.
The FDA recommends that all sterile products from NuVision be immediately quarantined and not administered to patients.
For more information visit the FDA website.