FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris
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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
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
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.
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
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
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, 6×28 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.
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 organism getting into the bloodstream
and producing more severe illnesses such as arterial infections (i.e., infected aneurysms),
endocarditis, and arthritis.
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.
Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination
Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.
Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts
GIANT Food Stores, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution following a supplier notification that the product may have Listeria monocytogenes.