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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.
Drug name Withdrawn Country Remarks Amphetamine Mix (Adderall XR) 2005 Canada Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found. [1] Alatrofloxacin: 2006 Worldwide Serious hepatotoxicity leading to liver transplant or death. [2] Alclofenac: 1979 UK Vasculitis [3] Alpidem (Ananxyl) 1995 Worldwide
In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers. [4] The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the ...
Consumers who may have bought the recalled products or who have questions can contact SunFed's recall hotline at (888) 542-5849, Monday through Friday from 8 a.m. to 5 p.m. Mountain Time.
FDA recalls over 7,000 bottles of antidepressant due to possible cancerous chemical. Drew Weisholtz. October 24, 2024 at 1:03 PM. Duloxetine, which can be sold under brand names like Cymbalta, is ...
More than 233,000 bottles of an antidepressant have been recalled by public health officials due to a chemical containing the risk of cancer.. The U.S. Food and Drug Administration classified ...
The recall was initiated after the FDA notified SunFed that the cucumbers were found to be connected to cases of salmonellosis illness reported between Oct. 12 and Nov. 15, 2024.
For drug Warning Letters, the information in the above sections 1.6-1.8 and 1.10 is in closing paragraphs as follows (bold type indicates optional/alternative language to be used as appropriate): [3] The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist [ at your facility/in connection ...