Drug Recalls -Medicine Recall - FDA
A pharmacy technician’s job is not just to assist a pharmacist, but also be aware of what’s happening in the industry. As part of their job, they must know that if a medication needs to be recalled the FDA or the manufacturer will have the responsibility to notify pharmacies and any location that has the product in question. Most drug recalls are voluntary. If a company discovers there is a problem with a product they will voluntarily recall the product. A company will also recall a drug product when concerns are raised by the FDA, in rare cases the FDA will request a recall.
Pharmacy wholesalers commonly send a list of drugs with NDC and lot numbers that have been recalled so that pharmacies can remove any such drugs from inventory “to protect the patient.” Pharmacy staff should immediately inspect and remove all drug products from the shelves, refrigerators and freezers. The pharmacy staff will store these recalled drug products in a separate area in the pharmacy.
There are three classes of recalls, and the FDA determines which class of recall is issued based on reports from the manufacturer and healthcare providers.
Class I - A reasonable probability exists that use of the product will cause or lead to serious adverse health events or death. An example of a product that could fall into this category is a label mix-up on a lifesaving drug.
Class II - The probability exists that use of the product will cause adverse health events that are temporary or medically reversible. One example is a drug that is understrength but that is not used to treat life-threatening situations.
Class III - The use of this product will probably not cause an adverse health event. Examples might be a container defect, off taste, or color in a liquid.
The most up-to-date list of recalled drugs is found on the U.S. Food and Drug Administration’s web site. All records go into the FDA’s weekly Enforcement Report. This Enforcement report lists each recall according to classification with the specific action taken. A recall is considered complete once all of the company’s corrective actions have been reviewed by the FDA and deemed appropriate. The FDA makes sure that the products are destroyed or suitably reconditioned, and then does an investigation as to why the product was defective in the first place.
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