McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb
Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 8, 2019 Category: Food Science Source Type: news

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 7, 2019 Category: American Health Source Type: news

FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use
FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 7, 2019 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency ’ s process for issuing public warnings and notifications of recalls
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 7, 2019 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency ’s process for issuing public warnings and notifications of recalls
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 7, 2019 Category: American Health Source Type: news

Statement from Binita Ashar, M.D., of the FDA ’ s Center for Devices and Radiological Health on agency ’ s continuing efforts to educate patients on known risk of lymphoma from breast implants
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

Statement from Binita Ashar, M.D., of the FDA ’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

Federal court enters consent decree against Ranier ’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

Federal court enters consent decree against Ranier ’ s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
FDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy ’ s Simply Naked Pita Chips
Frito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy ’ s Simply Naked Pita Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled pita chips bags. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 5, 2019 Category: Food Science Source Type: news

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy ’s Simply Naked Pita Chips
Frito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy ’s Simply Naked Pita Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled pita chips bags. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 5, 2019 Category: Food Science Source Type: news

Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “ Hipster Chipster ” Cookies
The Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “ Hipster Chipster ” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 5, 2019 Category: Food Science Source Type: news

Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “Hipster Chipster” Cookies
The Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “Hipster Chipster” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 5, 2019 Category: Food Science Source Type: news

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling
Dr. Reddy ’ s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it ’ s wholly owned subsidiary, Dr Reddy ’ s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 4, 2019 Category: Food Science Source Type: news