All about drug recalls

Food and drug recalls have been all over the news lately, from romaine lettuce to blood pressure pills. This can be frightening for many of us when we find out that we have bought the recalled product, but it can also be hard to figure out.

Here is how it works, and what you can do. In the United States, the Food and Drug Administration (FDA) regulates the health, safety, and labeling of foods, medications, and devices. If a consumer, manufacturer or the FDA finds a safety problem, the company who manufactured the product may issue a recall (voluntary recall), or the FDA can force the manufacturer to recall the product (mandatory recall). Sometimes the recall only affects future purchases (retail level recall), and only applies to retailers who stock the product. Other times, the safety risk is high, and anyone who purchased the product must be contacted, and advised to return the product for a replacement (consumer level recall).

In recent months, there has been news of several consumer level recalls on blood pressure medications. Through quality assurance testing, a contaminant was found in these recalled tablets called N-nitrosodiethylamine (NDEA).

NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and is classified as a probable human carcinogen. The recall continues to be expanded since October 2018, and now includes irbesartan, losartan, and valsartan, as well as combination products that contain these medications.

The Southern Ute Health Center Pharmacy receives daily alerts from our distributors, notifying us of any recalled products that we may have purchased. The pharmacy staff then reviews our stock and recently dispensed product list. Patients who have received a recalled product will be notified by telephone or mail, and asked to return the product for a replacement. All affected medications are mailed in to a collection service, and not dispensed.

If you think you are affected by these recalls, or have received a medication containing one of these products, check your medication bottle for a lot number. Compare the lot number with those listed on the FDA MedWatch website www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm. Call your pharmacist for more information.

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