FDA recalls NuVision drugs due to unsafe conditions, again
FDA recalls NuVision compounding pharmacy drugs over sterility concerns
Following a July safety inspection of the Downing Lab’s (aka NuVision Pharmacy) compounding pharmacy in Dallas, Texas, the FDA has issued a drug safety alert and a formal request to Downing Lab to immediately recall all of their drugs marketed as sterile. This is the second FDA recall of NuVision’s supposed sterile products in just two years. At an inspection in July of 2013, FDA inspectors observed unsanitary conditions and unsafe practices at NuVision’s facility. Yet again this July, inspectors observed unsanitary conditions at the facility and determined Downing Lab’s assurance of drug sterility was invalid. 19 lots of drug products failed to meet standards of sterility. In addition, three drugs in production tested positive for endotoxins, a microbial substance that can cause fever, shock, and circulatory complications. The FDA recommends healthcare providers check there supply of medications and quarantine any drugs produced by Downing Labs or NuVision Pharmacy. Patients who are taking NuVision medications are recommended to contact their healthcare providers for further information and to report any adverse side effects. On their website, NuVision offers a rather weak response to the FDA’s alert and recall. In summary, the group basically claims they adhere to all state and federal safety regulations, promise the public that no tainted drugs ever left the facility, and reassure everyone that they have made or are in the process of making every change recommended by the FDA. The fact that this is the second such incident in only two years leaves NuVision’s explanation a bit wanting.
Sources
The FDA’s letter to NuVision/Downing Labs can be seen here: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM413431.pdf
NuVision’s response here: https://nuvisionpharmacy.com/nuvision-pharmacy-responds-fda-med-alert/
A list of NuVision’s top selling drugs can be found here: https://nuvisionpharmacy.com/featured-compounds/
Michael Phelan is a Virginia trial attorney who practices with a special focus on traumatic brain injury (TBI) cases, pharmaceutical and medical device claims, product liability cases, and truck accidents. Michael’s peers have consistently recognized him for his excellence as a trial lawyer, and his clients have praised him for his commitment to deep research, his outstanding communication skills, and his sincerity and dedication.