Posts Tagged ‘food and drug administration’

GOPump & GOBlock Kits Recalled By FDA, Injuries Reported

Multiple news agencies have indicated that the Food and Drug Administration has issued a recall for all units of GoPump Rapid Recovery System kits and GOBlock Kits over a possible risk related to patient toxicity. According to the federal agency, these kits may present a risk because of a possible rapid influx of medication, which could lead to potential dysrhythmia or other adverse reactions. The firm Symbios Medical Products reported that up to this moment, at least five complaints related (read more)

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Portable Space Heaters Recalled By Optimus

Multiple news agencies have indicated that over 355,000 units of Portable Infrared Radiant Quartz Electric Space Heaters are being recalled by Optimus. The U.S. Consumer Product Safety Commission has stated that these space heaters are reportedly prone to fail when it comes to preventing a fire near combustible materials. These heaters were equipped with materials that could overheat, increasing the risk of a fire. If that occurs and the user doesn’t have enough time to turning the device off, the (read more)

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Recall Of Piperacillin & Tazobactam For Injection Expanded, FDA Reports

According to several news agencies, an additional recall was issued for more lots of Piperacillin and Tazobactam over a possible health risk. The Food and Drug Administration has reported that Apotex Corp. issued a recall for all units of at least 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams because the lots were discovered to potentially show precipitation or crystallization in IV bags. This could occur after reconstitution. The reports indicate that this recall was issued to (read more)

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FDA Could Be Looking Into Regulating Products Containing Caffeine

Multiple news reports show that the number of products that contain caffeine has been going up considerably in the last couple of years. Everything from sodas to even ice creams now are packed with caffeine. According to the Food and Drug Administration, only one product was allowed by the agency to be made with caffeine back in the 1950s: cola. Nowadays, every type of product may contain caffeine, even seemingly harmless gum and Cracker Jack’d Power Bites. Caffeine can negative (read more)

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Medtronic Announces Correction Notification For Medtronic DBS Lead Kits

According to a series of news reports, the Food and Drug Administration has reported that Medtronic Inc. has issued an Urgent Medical Device Correction notification concerning certain Medtronic DBS lead kits and dystonia therapy kits. According to the federal agency, these kits could pose an adverse reaction risk linked to a potential lead damage. The FDA has indicated that this alert or notification has been classified as a Class I recall. According to the firm, reports of damage associated to (read more)

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Potential Contamination Linked To Deli Meat Recall

Multiple news agencies have indicated that deli meats sold at Walmart are being recalled after the U.S. Department of Agriculture’s Food Safety and Inspection Service found strains of Listeria monocytogenes present in samples of the product. According to the federal agency, routine testing was responsible for the discovery of the contamination. Affected products are being pulled off shelves and Walmart stores that had the reportedly contaminated product for sale. Although this recall only affects certain states, Californians are urged to (read more)

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J&J’s LifeScan Recalls Blood Glucose Meters

Johnson & Johnson’s LifeScan, Inc. has issued a recall for certain OneTouch VerioIQ blood glucose meters due to a risk associated with the product’s accuracy. The company has stated that over 90,000 units of these meters could pose a risk due to an inadvertent shut off linked to readings that could be high. This problem could lead to a delayed treatment since the patient and the doctor may be unaware of the accurate blood glucose levels as a result of (read more)

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FDA Recalls Balanced Solutions’ Contaminated Injections

According to a series of news agencies, the Balanced Solutions Compounding Pharmacy, LLC has issued a recall for certain chromium chloride injections after the Food and Drug Administration tested the product to find gram negative bacteria as a result. The Food and Drug Administration has reported that these injections may have been contaminated due an issue during the quality control process, which is a sterility assurance problem. The FDA has reported that all units of the injections should be returned (read more)

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Compounded Products Recalled By Nora Apothecary & Alternative Therapies

Multiple news agencies have indicated that the Food and Drug Administration issued an alert associated with a recall of sterile compounded products by Nora Apothecary & Alternative Therapies. Multiple sources and the Food and Drug Administration stated that the multi-state recall affects compounded products the company supplies patients and health care facilities that were dispensed on or prior to the April 19, 2013 date. Up to this moment, the company hasn’t received any reports of incidents associated with the recall. (read more)

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After Fungal Meningitis Outbreak, FDA Vows To Be More Aggressive

Multiple news sources have reported that recently, a major outbreak of a rare form of fungal meningitis was linked to contaminated vials of drugs produced by the New England Compounding Center. The outbreak was responsible for 51 deaths and over 730 cases of illnesses associated with the contamination. This issue is now being addressed by the authorities as federal agency members testify before the House Energy and Commerce Subcommittee on Oversight and Investigations. According to some of the reports, the (read more)

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