FDA Trying to Get Drug Company to Issue Recall
The use of medications should be undertaken with caution and awareness. Patients have to trust that whatever drugs they take are safe. Most of the time, this is the case. But sometimes, defective drugs do make their way into circulation. When this happens the Food and Drug Administration may request that the company responsible for the drug issue a recall.
The FDA has had a contentious relationship with a company called NuVision Pharmacy for almost two years. At issue is the FDA’s request that the company perform a recall of its so-called “sterile products.” Additionally, the FDA is warning health care providers to avoid using drugs that were compounded by the company.
The request for recall is based upon the results of an inspection the FDA previously conducted at the company’s facility. During that inspection, the FDA claims that it found contaminated lots of what were reputed to be sterile drugs.
NuVision claims on its website that the contaminated lots had never been released. Additionally, the website’s statement also lists changes the company made in addressing the concerns issued by the FDA.
As of the writing of this post, NuVision had not agreed to the recall.
Companies involved in the production of pharmaceutical drugs must employ processes that decrease the chance of contamination to as near zero as possible. Should a drug rendered defective by contamination find its way into the public realm, that drug should be recalled as soon as its danger is evident.
Unfortunately, because of the expense and loss of profits, a pharmaceutical company may try to do whatever it can to avoid a recall. While the company may save some money, it may also put the health and welfare of consumers on the line.
If you ever suspect harm has come to you or a loved one due to a defective drug, a Texas defective drug lawyer may be able to help you seek accountability and compensation for your injuries.
Source: Fierce Pharma Manufacturing, “FDA fight with compounder tests its patience and its limits,” Sept. 11, 2014