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European regulators say there is not enough evidence to conclude that emergency contraceptives lose their effectiveness in women weighing 165 pounds or more, as one manufacturer had cautioned in its product labeling. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
The FDA has rejected a citizen petition filed by health advocacy group Public Citizen calling for a black-box warning about cardiovascular risks on testosterone products. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More
Manufacturers reporting adverse events suspected to be caused by vaccines should submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
The FDA admonished Concordia Pharmaceuticals for a telephone sales pitch about its attention deficit hyperactivity disorder drug Kapvay that omits critical risk and dosing information. Read More