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Message: <blockquote data-quote="Davy Crockett" data-source="post: 250000" data-attributes="member: 367">Where did you find that info eye ?   We mostly looked at discussion groups from people that had been using it recreationally and got hooked on it .      From other sources promoting it we gathered starting with a low dosage and gradually working up until you find the right dosage is critical .   From everything I have read , The good, bad and ugly of it I wish FDA and big pharma would embrace it and set up some standard guidelines.  Given the fact that there are 130 deaths each day from opioids overdose (Not counting liver and kidney failures) and 36 confirmed deaths total from kratom (being used with drugs , alcohol) I think it has been given a black eye from big pharma , FDA  and the media because it's "Natural" .    That's pretty scary what I posted about FDA recall on a med that I am on.    My wife showed me a KX13 story about it that was posted 3 hours ago.    Wonder if they watch this site ?      I also sent an email to ND pharmacy board looking for answers,  It's a revolving door of agencies pointing fingers at each other and nobody, Including FDA has pharma under control.     Something as simple as lot numbers are not recorded and kept on file.     This is a serious issue that needs attention.  me to ND board of pharmacy     I am wondering if you could share what procedures are in place for drug recalls and  what labeling information and record keeping is required by a pharmacy in North Dakota ?    One of my medications is listed on FDAs drug recall page and my pharmacy has assured me that my prescription is not part of this recalled since it was manufactured by another company.     Upon more questions of the recall procedures I was told they could not provide me with the lot #  that my prescription was filled from .     For safety reasons as a consumer it threw a red flag so my main question I guess is why are lot numbers not required to be printed on the labeling provided by pharmacies ?Their responseThanks for the question, nationally pharmacies have not had a standard to track lot numbers of commercially available product to the patient level outside of when they are conducting compounding.  Much of the reason is likely how the FDA treats and operates drug recalls.  The FDA has different level of recalls with the most serious being when a pharmacy would need to reach out to patients to pull back product not being tied to an individual lot number but affecting an entire manufacturer’s line of a medication (in the industry referred to a NDC number)  The recall that the FDA issued that you likely experienced was a lower level recall which typically affects certain lots of product which does not require the pharmacy to attempt to reach the patient to pull back product. In this case they would examine their inventory for those specific lots to be quarantined and sent back.  These recalls are usually initiated by the manufacturer based on reports they receive from patient or health care providers. Essentially our requirements for pharmacies would be to follow the recall procedures that would be initiated by the FDA. Their wholesaler would be required to communicate recalls of affected products that they would have sent to the pharmacy.  The level of the recall, set by the FDA, would determine the action the pharmacy would need to take in regards to notifying patients and/or to quarantine product for return.  Documentation of the action taken should be kept for review by appropriate authorities if needed.In saying this there are some new laws being implemented to have electronic track and trace technology in the drug supply chain which may eventually get to the point of tracking individual lots to the patient level in an electronic format. I see that as a great opportunity for better care given the complexities of medication therapies moving forward.Hope that provides some understanding to the process of recalls.</blockquote>

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