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Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year. Read More
New Jersey-based compounder Pharmacy Creations is recalling one lot each of four products after a former testing laboratory found that the lots in question may not be sterile. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More
Pharmaceutical companies want to maintain the current exemption on reporting financial support for continuing medical education (CME) programs under the Physician Payment Sunshine Act, a position that is under threat from a new proposed rule. Read More
Johnson & Johnson is pulling its OTC nausea and vomiting drug domperidone from the UK market following a decision by regulators that the medicine must require a prescription to obtain due to risks of serious cardiac effects. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials, and nine lots due to particulates in vials. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
Drugmakers are pushing back against an FDA plan to implement tough restrictions on distributing information about new, off-label benefits of a drug, while loosening restrictions on disseminating journal articles that present new risk information about their products. Read More
In an effort to dispel a perception that Indian drugs are poorly made, the government is offering whistleblowers a hefty reward for providing information on spurious, adulterated and misbranded products. Read More