A Dallas compounding pharmacy has been cited for safety violations in the manufacture of its drugs. The latest inspection of the pharmacy uncovered some potential health concerns. The same pharmacy last year refused to recall some of its drugs after the Food and Drug Administration found contamination.
Most recently, Downing Labs in Farmers Branch was cited for failing to investigate why its drugs failed sterility tests that the FDA performed. The FDA said that some spore forming bacteria are routinely recovered in the processing areas of the lab, and that the company failed to properly investigate. The FDA also alleged that the lab did not have adequate procedures to prevent drug contamination or ensure drugs are the correct strength, and that some bottles did not give required information about the drugs.
The pharmacy agreed to voluntarily recall all of its sterile drugs, and promised to implement changes. The products in question were sold nationwide, as well as in the United Kingdom, between April and September. The pharmacy has asked patients and health care providers not to take or administer the drugs. Fortunately, it has received no complaints or reports of adverse reactions to the recalled drugs.
Compounding pharmacies such as Downing Labs tailor certain drugs to individual patients, normally in small batches. They used to work like independent neighborhood pharmacists, but in recent years have sold drugs to doctors and hospitals, making them more like drug manufacturers. Compounding pharmacies made national news in 2012 when a Massachusetts compounding pharmacy’s contaminated drugs resulted in the deaths of 64 people.
Compounding pharmacies, much like drug manufacturers, are legally liable when they manufacture a contaminated drug that harms consumers. If you have been injured by a prescription drug, and you believe it’s due to the negligence of the drug company or compounding pharmacy, call the Houston personal injury attorneys at Kennedy Hodges at 855-947-0707. Call us today to learn more or visit us on Twitter.