Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination
Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration ( “FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 21, 2018 Category: Food Science Source Type: news

Now Health Group Inc. Recalls Select Now Real Food ® Zesty Sprouting Mix Because of Possible Health Risk
NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food ® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, a nd others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can res...
Source: Food and Drug Administration - June 21, 2018 Category: Food Science Source Type: news

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA ’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA ’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 19, 2018 Category: American Health Source Type: news

Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour
Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 19, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 19, 2018 Category: American Health Source Type: news

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk
Del Monte Fresh Produce N.A., Inc. ( " Del Monte Fresh " ) announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 16, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 15, 2018 Category: American Health Source Type: news

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk
Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg ’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 14, 2018 Category: Food Science Source Type: news

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
: FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 14, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’ s efforts to better equip consumers with nutritional information about dietary fiber in their food
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’ s efforts to better equip consumers with nutritional information about dietary fiber in their food (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 14, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s efforts to better equip consumers with nutritional information about dietary fiber in their food
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s efforts to better equip consumers with nutritional information about dietary fiber in their food (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 14, 2018 Category: American Health Source Type: news

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens
World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 13, 2018 Category: Food Science Source Type: news

Dave ’ s Pet Food Voluntarily Recalls 95% Premium Beef Canned Dog Food Due to Potentially Elevated Levels of Thyroid Hormone
Dave ’ s Pet Food of Agawam, MA is recalling a single lot of Dave ’ s Dog Food 95% premium beef cans because the products potentially contain elevated levels of beef thyroid hormone. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: Food Science Source Type: news

Dave ’s Pet Food Voluntarily Recalls 95% Premium Beef Canned Dog Food Due to Potentially Elevated Levels of Thyroid Hormone
Dave ’s Pet Food of Agawam, MA is recalling a single lot of Dave’s Dog Food 95% premium beef cans because the products potentially contain elevated levels of beef thyroid hormone. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’ s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 12, 2018 Category: American Health Source Type: news

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk
Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 9, 2018 Category: Food Science Source Type: news

Federal judge enters consent decree against Delta Pharma
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 8, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 7, 2018 Category: American Health Source Type: news

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 6, 2018 Category: American Health Source Type: news

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act
FDA ’ s Anna Abram ’ s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 6, 2018 Category: American Health Source Type: news

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers
by aligning USDA program with FDA ’s Produce Safety Rule requirements. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 5, 2018 Category: American Health Source Type: news

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 5, 2018 Category: American Health Source Type: news

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 5, 2018 Category: American Health Source Type: news

Shearer ’ s Foods, LLC Issues an Allergy Alert for Undeclared Milk in Meijer Brand Dill Pickle Flavored Potato Chips
Shearer ’ s Foods, LLC of Massillon, OH is recalling Meijer brand 9.5 ounce packages of Dill Pickle Flavored Potato Chips because they may contain undeclared milk. People who are allergic to milk run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 5, 2018 Category: Food Science Source Type: news

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 4, 2018 Category: American Health Source Type: news

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject ™ Syringe System due to the Potential Presence of Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 4, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA ’ s drug review office
FDA has proposed an important series of new steps to modernize the organization and functions of CDER ’ s Office of New Drugs. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 4, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA ’s drug review office
FDA has proposed an important series of new steps to modernize the organization and functions of CDER ’s Office of New Drugs. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 4, 2018 Category: American Health Source Type: news

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites
Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 2, 2018 Category: Food Science Source Type: news

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits
SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared milk allergen. Consumers who are allergic to milk allergen may run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 1, 2018 Category: Food Science Source Type: news

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags
On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 1, 2018 Category: Food Science Source Type: news

Abbott Implements Corrective Action for Heartmate 3 Heart Pump
Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 ™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’ s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
FDA ’ s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
FDA ’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: American Health Source Type: news

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles
Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: American Health Source Type: news

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment
Committed to the quality of its products, H-E-B is voluntarily issuing an all-store recall for certain flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets for broken metal in processing equipment found during routine maintenance. The affected products were distributed to stores in Texas and Mexico. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 31, 2018 Category: Food Science Source Type: news

FDA approves first artificial iris
, a surgically implanted device to treat aniridia or other damage to the iris (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA ’ s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo
FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA ’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo
FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act
FDA stands ready to implement the Right to Try Act in a way that achieves Congress ’ intent to promote access and protect patients (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

FDA approves new treatment for moderately to severely active ulcerative colitis
FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
(Source: Food and Drug Administration)
Source: Food and Drug Administration - May 30, 2018 Category: American Health Source Type: news

Allergan Issues Nationwide Voluntary Recall of TAYTULLA ® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA ® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 29, 2018 Category: Food Science Source Type: news

Allergan Issues Nationwide Voluntary Recall of TAYTULLA ® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA ® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample p ack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 29, 2018 Category: Food Science Source Type: news

Pious Lion Voluntary Recall Due to Possible Health Risk
Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organis...
Source: Food and Drug Administration - May 29, 2018 Category: Food Science Source Type: news

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand
Global Commodities, Inc. of Hicksville, NY is recalling 1lb and 0.5lb packages of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt, because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 26, 2018 Category: Food Science Source Type: news