FDA warning: Don’t use sterile products from NuVision Pharmacy

The FDA issued a reminder to health care providers not to administer any sterile products made and distributed by NuVision Pharmacy of Dallas because their sterility is not assured.

This alert follows the FDA’s notice on May 18 recommending that health care providers immediately check their medical supplies for NuVision Pharmacy sterile products, quarantine those products, and not administer them to patients.

However, the agency says that NuVision Pharmacy has repeatedly declined to recall its sterile products. The FDA most recently issued asked NuVision on July 26 to immediately recall all lots of sterile products produced at NuVision that have not passed their expiration dates.

During an FDA inspection of NuVision’s Dallas facility in April, FDA investigators observed poor sterile production practices.

In April 2013, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with quality control processes identified during the FDA’s April inspection. The FDA received adverse event reports of fever, flu-like symptoms and soreness at the injection site associated with the methylcobalamin injection product that was recalled. The agency is unaware of any adverse event reports associated with other sterile products from NuVision.

The FDA asks health care providers and consumers to report adverse reactions or quality problems experienced with use of any NuVision product to the FDA’s MedWatch Adverse Event Reporting program by:

• completing and submitting a reporting form at www.fda.gov/medwatch/report.htm; or

• downloading and completing the form, and then sending it by fax to 1-800-FDA-0178.