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Sterile compounded drug products voluntarily recalled
Compounded drug products are being voluntarily recalled due a lack of sterility assurance.
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Johnson & Johnson ordered to pay $8bn in Risperdal case
A jury has said that Johnson & Johnson must pay $8 billion in the case over male breast growth linked to Risperdal.
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MHRA announces recall of Zantac products made by GSK
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
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FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
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FDA and DEA send joint warning letters to illegal opioid sites
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products.
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J&J reach $20.4m settlement agreement over opioid trial
Johnson & Johnson have reached a settlement with two Ohio counties over its role in the opioid crisis, removing the company from the trial due to begin later this month.
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Drugmakers may use Purdue’s bankruptcy to settle opioid suits
Drugmakers that face litigation over the opioid crisis are looking at ways to settle the cases by using Purdue's bankruptcy, it has been reported.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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Daratumumab approved for multiple myeloma treatment
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
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How will technology aid an ageing world?
This article explores the potential of readily available technology to address current traceability challenges as well as more wide-ranging issues in the pharmaceutical industry.
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Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
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Losartan drug recall expanded to include five more lots
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
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Partnership between the BP and USP to be formalised
The British Pharmacopoeia and United States Pharmacopeia partnership is to be formalised to strengthen the quality of medicines and public health.
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Two lots of quinacrine recalled due to labelling error
Darmerica LLC is voluntarily recalling two lots of quinacrine dihydrochloride due to a label mix-up.
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Company sues FDA over rejecting opioids intended to deter abuse
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.