FDA

NECC: 14 executives, staff arrested and charged

I’m one of seven lawyers on the Plaintiffs Steering Committee involved in litigation involving this national tragedy – deaths and injuries resulting from contaminated steroid injections. News yesterday about arrests: Law enforcement agents swooped in during predawn raids Wednesday and arrested executives and former staffers of a Framingham compounding pharmacy blamed for producing tainted drugs that killed dozens in one of the deadliest medication contamination cases in US history. In all, 14 people were charged in connection with the 2012 fungal meningitis outbreak linked to the shuttered New England Compounding Center. Contaminated drugs — produced with expired ingredients under unsterile …

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FDA Warning Letter -Hyland Acres Jerseys, Ltd.

Here’s the warning letter – finding illegal drug residue, found the presence of 20.99 parts per million (ppm) of neomycin in the kidney of a calf. WARNING LETTER WL-15-444065-10 Ronald J. Kandel, Partner Larry D. Alexander, Partner Jerry Schonauer, Partner Hyland Acres Jerseys Ltd. 5306 County Road 51 Big Prairie, Ohio  44611 Dear Messers. Kandel, Alexander, and Schonauer: On September 22 and October 16, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5306 County Road 51, Big Prairie, Ohio 44611. This letter notifies you of the violations of the Federal Food, Drug, and …

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FDA: Idaho Knew About Chobani Mold Problem Before 2013 Recall

A federal report obtained under the Freedom of Information Act (FOIA) suggests that that the Idaho Department of Agriculture knew about  Chobani yogurt that had mold, almost  two months before it was recalled.The EIR is found online now, thanks to the FOIA request . From the EIR “In July the routine Grade A sampling and testing samples taken by the Idaho Department of Agriculture (ISDA) from the Chobani Idaho Inc. production were visually noted, by the laboratory technician, that surface defects were present and additional testing was conducted noting a yeast like growth developing in the yogurt samples. ISDA followed-up with Chobani Idaho …

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Overmedicating the Elderly: Chemical Restraint in American Nursing Homes

Robert Sachs, Esq. A troubling reality of drug abuse in American nursing homes is coming to light through class action lawsuits and personal stories. Family caretakers and elderly advocates are discovering a dark system of drug abuse inflicted on their elderly parents and loved ones, often when it is too late. Almost 300,000 residents currently receive antipsychotic drugs, including Risperdal, Haldol, and Seroquel, which approved to treat severe schizophrenia and bipolar disorder. However, nursing homes employ them instead to sedate, suppress, and immobilize residents, often claiming that it suppresses aggression, and anxiety that come with dementia and Alzheimers disease. Some …

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FDA Orders New Warnings on OTC Acetaminophen Drugs

A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions. Find it here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424898.pdf         See more at: http://www.raps.org/Regulatory-Focus/News/2014/12/01/20858/FDA-Orders-New-Warnings-on-OTC-Acetaminophen-Drugs/#sthash.2qp4YKul.dpuf

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