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Latest News | 21 May 2013

Industry Slams Device Recall Guidance, Highlighting Perceived Flaws

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The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of Read More...


Latest News | 21 May 2013

Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems

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Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at Read More...


Latest News | 16 May 2013

Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

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Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and Read More...


Latest News | 15 April 2013

Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month

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Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary Read More...


Latest News | 26 March 2013

Imaging Device has Potential to Display Other Patients' Images, Says Company in Recall Notice

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When undergoing a medical imaging procedure, patients expect some measure of clarity. If for instance, a patient goes in for an angiography, they expect their doctor to be able to use the image to Read More...


Latest News | 26 March 2013

Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

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A steady drumbeat of recalls from compounding pharmacies has struck a note for the third time in approximately a week, with Massachusetts-based Pallimed Compounding Pharmacy issuing a notice Read More...


Latest News | 21 March 2013

Second Compounding Pharmacy Recalls all Products After Sterility Concerns Raised

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For the second time in a single week, a US-based compounding pharmacy has announced the recall of all of its compounded products, again due to contamination affecting supposedly sterile products.The Read More...


Latest News | 18 March 2013

Another Compounding Pharmacy in Spotlight as it Recalls all Products Due to Contamination

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Another US-based pharmaceutical compounding pharmacy has recalled all of its products after it said they could potentially be contaminated with mold.A similar recall was initiated in 2012 by the New Read More...


Latest News | 25 February 2013

Takeda, Affymax Recall All Lots of Anemia Drug as Advisory Committee Remarks Prove Prophetic

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Pharmaceutical companies Affymax and Takeda have announced a recall of all lots of their Omontys drug after becoming aware of more than a dozen cases of anaphylaxis, of which three were fatal to Read More...


Latest News | 3 December 2012

Indian Regulators Finalize Recall System Requirements

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Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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