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FDA Recalls / Safety Alerts

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drreddys march27 Dr. Reddy's Laboratories Ltd. is recalling four lots of Phytonadione Injectable Emulsion Ampules, the U.S. Food and Drug Administration said in a statement. The recall was initiated after receiving complaints of ampules breaking and shattering, upon opening, during compounding. Dr. Reddy's said it has received reports of cuts in skin and lacerations to health care professionals.

guansmushroom march23 Commerce, California-based Guan's Mushroom Co. is recalling Enoki Mushroom citing possible presence of Listeria monocytogenes, a bacteria that can cause life-threatening illness or death, the U.S. Food and Drug Administration said in a statement. The recall involves all cases of 200g/7.05 ounce packages of Enoki Mushroom, which is produced in Korea.

rawseafoods march19 Raw Seafoods, Inc. is recalling two Wegmans branded salmon products for the presence of undeclared wheat allergen, the U.S. Food and Drug Administration said in a statement. The recall involves Wegmans Brand Ginger Salmon Oven Safe Meal and Salmon Teriyaki Oven Safe Meal. However, the company has not received reports of illness so far.

chicagoindoor march18 Chicago Indoor Garden is recalling clover sprouts and all related products citing E. coli concerns, the U.S. Food and Drug Administration said in a statement. The company's Red Clover sprouts, with Best By dates between 12/1/19 through 3/12/20, may have been contaminated with Escherichia coli O103 or E. coli 0103.

sunhong march12 Sun Hong Foods, Inc. recalled all cases of Enoki Mushroom, citing possible presence of Listeria monocytogenes, a bacteria that can cause life-threatening illness or death, the U.S. Food and Drug Administration said in a statement. The recall was initiated after 36 people were infected with Listeria, in which 4 people died and 30 were hospitalized after eating Enoki Mushrooms.

hikmaextends march09 Hikma Pharmaceuticals USA Inc., the U.S.-based business of Hikma Pharmaceuticals PLC, extended its previously announced recall of certain lots of pain and inflammation medication Ketorolac Tromethamine in the form of injection for the potential presence of small visible particulate matters.

dolefresh march09 Dole Fresh Vegetables, Inc. is recalling H-E-B-branded Tuscan Herb salad kit citing possible undeclared allergens such as peanut, wheat, soy and tree nuts, the U.S. Food and Drug Administration said in a statement. The recall involves Tuscan Herb Chopped Salad with best by date of March 11, manufactured by Dole for H-E-B. The products were sold at H-E-B stores across Texas.

vita march06 Chicago, Illinois -based Vita Food Products, Inc. has recalled Vita Wild Herring in Wine Sauce for potential mislabeling, the U.S. Food and Drug Administration said in a statement. The products contain sour cream and, therefore, may contain undeclared milk, a known allergen. The recall involves up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce.

wholefoods march04 Whole Foods Market, the supermarket chain owned by e-commerce giant Amazon, is recalling select Green Chile Chicken Tamales across multiple states due to undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The company has not received any reports of allergic reactions related to these products.

animalfeed mar02 Purina Animal Nutrition is recalling select animal feed in Purina, Country Acres, DuMOR brands over concerns of elevated calcium levels, the U.S. Food and Drug Administration said in a statement. The recall involves multiple lots of Purina Rabbit and Turkey Feed, Country Acres Rabbit Feed, as well as DuMOR Chick Starter/Grower Feed.

sierrasoups feb26 California-based Sierra Soups is recalling "Pasta e Fagioli" soup mix for concerns of undeclared gluten, the U.S. Food and Drug Administration said in a statement. The soup mix contained an individually wrapped package of pasta that contains gluten, a known allergen. However, the outer packaging states the product is Gluten Free. The problem was caused by a breakdown in the packaging processes.

medman feb25 Med Man Distribution expanded its recall for dietary supplements including all lots of "Bow and Arrow libido enhancer for men" for the potential undeclared presence of sildenafil, the U.S. Food and Drug Administration said in a statement. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The company had earlier in November 2019 recalled all lots of Up2 dietary supplement.

taropharma feb24 Taro Pharmaceuticals U.S.A., Inc., the U.S.-based business of Israeli Pharma firm Taro Pharmaceutical Industries, Ltd., recalled certain lots of seizure medication Phenytoin in the form of oral suspension for potential underdosing or overdosing, the U.S. Food and Drug Administration said in a statement. The company found that the oral suspension may not re-suspend when shaken.

cjfoods feb18 CJ Foods, Inc., a division of CJ America, Inc., recalled Annie Chun's Japanese-Style Teriyaki Noodle Bowls due to undeclared peanuts, the U.S. Food and Drug Administration said. The La Palma, California-based company initiated the recall after discovering that some bowls that were packaged in outer sleeves indicating Teriyaki Noodle Bowls contain Pad Thai noodle, which contains peanuts.

medtronic feb13 Irish medical technology company Medtronic plc is recalling certain MiniMed insulin pumps for Type 1 diabetes after incorrect insulin dosing by the device caused thousands of injuries and one death, the US Food and Drug Administration announced. In a statement, the health regulator identified this as a Class I recall, the most serious type of recall.

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