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Drug Recalls

Just about everyday I receive an email from the FDA titled Recalls. If you don't have time to read every one of the many newsletters, notices, and subscribed emails I'm sure you receive daily, make time to glance at the FDA recalls email (and the Tuesday Talks with John, of course). Oftentimes clients call me and say, "I just heard about this recall and it happened months ago!" They feel behind the eight ball and struggling to catch up. Sometimes wholesalers are delayed reporting the recall to their customers. My best advice is to keep an active eye on that FDA recall list and make sure you're not affected.

You've received an FDA notice for a drug recall, and OH NO, you stock that drug! Where do you go from here? Step one: check your existing drug stock. The FDA recall notice will include information on the affected lot numbers. If you have one of those lots, pull them from stock and label them "DO NOT USE". Step two: determine if action is necessary. What kind of recall is this? Why was the drug recalled? See below for the definitions of recall classes to determine whether patient notification might be necessary. Is there a chance that affected drug was administered to patients, and if so, is there potential for harm? Step three: Contact your wholesaler. If you don't already know which lots you purchased, find out. They are required to keep pertinent drug transaction data, such as lot numbers, by law. If you've checked your shelves and you do not have the affected lots in stock, it's still a very good idea to check your purchase history. If you are affected, you'll want to find out what to do next. For some recalls, manufacturers want the drug returned to them for testing. In other instances, manufacturers might tell you to dispose of the drug. In any case, if you're affected, either the wholesaler or manufacturer should issue a credit or replace the drug you've lost. Step four: manage the potential for a shortage. Depending on the type of recall and how far-reaching it is, you could be heading towards a shortage. Immediately consider this possibility, and if you determine that a shortage is likely, begin preparing.

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