The Food and Drug Administration recently issued an inspection report pertaining to Downing Labs for failing to investigate why its drugs fail sterility tests. Last year, FDA requested that Downing Labs recall some of its drugs after determining that there was contamination. At that time, Downing Labs refused the request. Now, however, the pharmacy has announced a voluntary recall of sterile drugs and said it will implement changes. The prescription drugs at issue were sold nationwide and in the United Kingdom between April 20 and Sept 15, 2015. Patients and providers are being instructed not to take or administer the drugs.
FDA inspectors determined that Downing Labs failed to properly investigate other failed tests like those for drug potency. Downing Labs was also cited for having inadequate procedures to prevent drug contamination or ensure drugs are the correct strength. FDA also reported that Downing Labs did not test some drugs that it claimed to be free from certain contaminants. In addition, the labels on some bottles didn’t give required information such as the drug name, dosage, active ingredients and a notice saying it’s a compounded drug.
http://thescoopblog.dallasnews.com/2015/10/dallas-drug-compounder-issues-recall-after-fda-finds-contamination.html/
