FDA Drug REcall List
FDA Doesn't catch all bad drugs
December 7, 2017
Although the attorneys at TheLawFirm.com often write about defective drugs, it is alarming to review the FDA drug recall page. While it might be comforting to think the FDA catches most problems with the drug manufacturing process, we believe that is unlikely to be true. Hence our alarm when we review some of the reasons for drugs to be recalled. A review of just part of 2017 drug recalls includes recalls for microbial contamination, both sub potent and super potent tablets, particulate matter, mislabeled drugs, general violations of current good manufacturing practice regulations, a lack of sterility assurance, product exposed to subfreezing temperatures, unapproved new drug, tainted drugs, misprinted dosing droppers, containing undeclared drugs, presence of anabolic steroids, undeclared milk allergen, potential for product to be below specification, tablet mix-up, concerns of manufacturing practices and a labeling mix-up.
Each of these reasons for drug recall is concerning. What is scary, however, is how many other drugs probably slipped through the manufacturing process. We recited this list in the hopes that patients would consider three facts that we consider to be true: first, that the FDA can probably only catch a small percentage of manufacturing errors. Second, that many manufacturing errors are serious, and potentially deadly. Third is that drug manufacturers can, and do, make mistakes. We expect that many of these problems are due to the serious problem of putting profits over people. Some of the errors, such as exposing a drug to subfreezing temperatures, may be simply a by-product of weather. However it is much harder to justify mistakes such as ‘unapproved new drug’ or ‘general violations of good manufacturing practices’.
According to the FDA, “recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. See Definitions of Market Withdrawals and Class I, II, and III recalls. All recalls (Class I, II, and III) can be found in the FDA Enforcement Report.
In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified. These unclassified recalls will be published in the Enforcement Report every Wednesday, and will be listed under the heading, “Human Drug Product Recalls Pending Classification.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
If you have a medicine that has been recalled, talk to your health care professional about the best course of action. Stores generally have a return and refund policy when a company has announced a recall of its products.
NOTE: The recalls on the list are generally Class I., which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Patients and consumers can see the list of recalled drugs at https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm.
As always, the attorneys at TheLawFirm.com stand ready to hold corporations accountable when they produce either a defective drug or have sloppy manufacturing practices that hurt or kill innocent Americans.
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