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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.
2009, 84 Nigerian children were reported to have died after being given "My Pikin", a teething syrup contaminated with diethylene glycol. [ 18 ] 2012: As of 2 November 2012 [update] in the New England Compounding Center meningitis outbreak , 753 cases of fungal infection occurred with 64 deaths due to contaminated injectable medication.
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware ...
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2007 Chinese export recalls; ... 2010 DePuy Hip Recall; 2010 Johnson & Johnson children's product recall; C. Chicago Tylenol murders; D. Drug recall; E.
The 2010 Johnson & Johnson children's product recall involved 43 over-the-counter children's medicines announced by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, on April 30, 2010. Medications in the recall included liquid versions of Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl. The products were recalled after it was ...