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2012 – 2018: From 2012 to 2018 massive amounts of generic versions of an entire class of angiotensin II inhibitor blood pressure medications (collectively called "sartans") were made with contaminated ingredients. Patients receiving these drugs were exposed to genotoxic and carcinogenic N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine ...
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
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]
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.
The company Alcon Laboratories, maker of a popular brand of eye drops, recalled some of its nationwide stock on Dec. 23, after discovering a fungal contamination in one of its products.
The Food and Drug Administration issued a nationwide recall of single-use eyedrops. One lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was recalled over ...
On November 20, 2018, the CDC, [105] the U.S. Food and Drug Administration (FDA), and Health Canada [106] announced that they were investigating a multistate binational outbreak of pathogenic Escherichia coli O157:H7 infections linked to romaine lettuce. This outbreak was separate from the previous outbreak traced to Yuma, Arizona.
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...