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In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet". [3] Similar documents attached to the outside of a package are sometimes called outserts. [citation needed]
A ganglion cyst is a fluid-filled bump associated with a joint or tendon sheath. [3] It most often occurs at the back of the wrist, followed by the front of the wrist. [3] [4] The cause is unknown. [3] The underlying mechanism is believed to involve an outpouching of the synovial membrane. [4] Diagnosis is typically based on examination.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
Here's a full list of recalled eye drops and more context on why federal regulators have placed these on recall lists in the first place: EzriCare Artificial Tears Lubricant Eye Drops: According ...
Federal food regulators raised their alarm for recalled eggs sold from Costco stores over possible salmonella exposure, reclassifying the targeted product to its highest risk level.. The FDA a ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
[17]: 12 Reintroduced as a dietary supplement in 2006; [17]: 13 in 2013 the FDA started work to ban it due to cardiovascular problems [18] Dinoprostone: 1990 UK Uterine hypotonus, fetal distress. [3] Dipyrone 1975 UK, US, Others Agranulocytosis, anaphylactic reactions. [3] Dithiazanine iodide: 1964 France, US