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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.
It requires an applicant that does not agree to the request for a pediatric study to submit to the Secretary the reasons such pediatric formulations cannot be developed, and requires an applicant that agrees to the request to provide the Secretary with all post-marketing adverse event reports regarding the drug. It directs the FDA to: (1 ...
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.
A CVS spokesperson told Fortune its recalled store-brand over-the-counter products make up fewer than 1% of the FDA’s drug recalls in the past 10 years. It also completes an average of 350 daily ...
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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.
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 ...