FDA forms work group on drug importation policy options to address certain patient access challenges
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H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment
H-E-B is voluntarily issuing a recall for two variety packs of Creamy Creations ice cream and sherbets in 3-ounce cups due to broken metal found in processing equipment during routine maintenance. The potentially affected products were distributed only to H-E-B stores in Texas. Please note, the product was not distributed to the Houston area or Mexico.
Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns
Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses
WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) and 3 pound (48 oz.) containers produced between June 1, 2018, and July 13, 2018, and available from the deli service case.
New York-based food processors agree to stop food preparation operations due to food safety violations
New York-based food processors agree to stop food preparation operations due to food safety violations
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets
Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs
FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers
The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens
Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.