Archive for the ‘Food & Drug Recalls’ category

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

September 27, 2018

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

September 26, 2018

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 – 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm’s operations. […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

September 26, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

September 25, 2018

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

September 25, 2018

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

September 25, 2018

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

September 24, 2018

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

September 21, 2018

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume […]

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

September 20, 2018

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora

September 18, 2018

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food […]

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

September 18, 2018

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.

Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen

September 18, 2018

Lidl US has voluntarily recalled all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections as a precautionary measure because the allergen statement does not include wheat.

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids

September 18, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids.

FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

September 18, 2018

FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.

FDA approves device for treatment of acute coronary artery perforations

September 14, 2018

FDA approves device for treatment of acute coronary artery perforations

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

September 14, 2018

FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

September 13, 2018

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected […]

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

September 13, 2018

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA approves new kind of treatment for hairy cell leukemia

September 13, 2018

FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

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