- FDA Calls For Recall of Downing Labs Products
- September 30, 2014 | Author: Jennifer L. Keel
- Law Firm: Burg Simpson Eldredge Hersh & Jardine, P.C. - Englewood Office
The U.S. Food and Drug Administration has issued a formal request to Downing Labs, asking for the company to recall all of its purportedly sterile products immediately. The FDA found poor conditions and practices at Downing Labs' facility in Dallas during an inspection in July 2014, and has concerns about whether the company's products are actually sterile.
The inspection found sterility failures in 19 lots of drug products from the company, as well as endotoxin failure in three lots of drug products. Endotoxins, found in some bacteria, can cause fever, shock, changes in blood pressure and other serious reactions. Downing Labs failed to investigate or otherwise address any of these failures. The FDA found possible sources of contamination were raw materials used in the drugs and aseptic technique. The impacted drugs included cyanocobalamin and folic acid, as well as green tea caplets, terbutaline and procaine.
The FDA has already asked health care professionals and consumers not to use any drugs marketed as sterile produced by Downing Labs, which is also known as NuVision Pharmacy. Administering a nonsterile drug product meant to be sterile could create serious and potentially deadly infections.