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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.
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 ...
The recall covers 7,107 bottles of duloxetine, the FDA said. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024.
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 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 ...
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. Alcon, the ...
The Food and Drug Administration (FDA) announced a nationwide recall of a popular single-use eye drop on December 23. Alcon Laboratories, maker of Systane eyedrops, voluntarily recalled one lot of ...
A Duloxetine recall by the FDA has flagged more than 7,100 bottles of the Cymbalta generic drug due to a cancerous chemical.