The FDA is reminding healthcare providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas.
Providers should not administer any NuVision Pharmacy sterile products to patients because the products sterility is not assured, according to an FDA notice.
This alert follows the FDAs notice on May 18 recommending that providers and other healthcare professionals, including hospital staff, immediately check their medical supplies for NuVision Pharmacy sterile products, quarantine those products and not administer them to patients.
NuVision Pharmacy has repeatedly declined to recall its sterile products, the FDA stated. The FDA most recently issued a letter to NuVision on July 26, requesting an immediate recall of all lots of sterile products that have not passed their expiration dates and were produced at NuVision.
In the letter, the FDA outlined poor sterile production practices observed by investigators during an April inspection of NuVisions Dallas facility. The FDA explained that those practices raised concerns about a lack of sterility assurance of NuVisions sterile drug products. The FDA noted that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections.
NuVision responded to the letter by refusing to recall its sterile products, the FDA stated. Under its authority, the FDA cannot require NuVision to undertake such a recall. Therefore the agency reminds healthcare providers not to use any sterile products from NuVision.
In April, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during that month’s FDA 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 previously was recalled. The agency is not aware of any adverse event reports associated with other sterile products from NuVision.
Patients who were administered any sterile drug product produced and distributed by NuVision and who have concerns should contact their healthcare provider. The FDA asks providers and consumers to report adverse reactions or quality problems experienced with the use of any NuVision product to the FDAs MedWatch Adverse Event Reporting program by completing and submitting the report online at www.fda.gov/medwatch/report.htm, or downloading and completing the form and submitting it via fax to 1-800-FDA-0178.
Read the FDAs letter to NuVision: http://1.usa.gov/13FVBC7.
On its website, NuVision Pharmacy wrote that it is in compliance with U.S. Pharmacopeial Convention standards for compounding pharmacies. “The FDA manufacturing law is different than USP. The current state laws do not require compounding pharmacies to follow the standards for manufacturing.
“All of our sterile injectables are tested by a third-party lab for sterility prior to dispensing. For anyone with questions or concerns about the sterility of our products, NuVision Pharmacy will send you the results proving that our products are sterile.”