Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news
Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream
Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product ’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news
Mondel ē z Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ē z Global LLC announced today a
limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news
Mondel ēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ēz Global LLC announced today a
limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health eff ects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news
Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with < em > Salmonella < /em >
Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella.
The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news
FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news
Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry ’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint
Unilever is voluntarily recalling a limited quantity of Ben& Jerry ’s Coconut Seven Layer Bar bulk and Ben& Jerry ’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the bac k of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the recalled products. (Source: Food a...
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news
FDA takes action to protect women ’ s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news
FDA takes action to protect women ’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news
Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk
Caito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut 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 Carrau, 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 (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salm...
Source: Food and Drug Administration - April 13, 2019 Category: Food Science Source Type: news
Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news
FDA approves first targeted therapy for metastatic bladder cancer
The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news
Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk
FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news
SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil
SD Import, LLC is voluntarily recalling all lots of Aphrodisiac, Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 11, 2019 Category: Food Science Source Type: news
FDA orders important safety labeling changes for Addyi
FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 11, 2019 Category: American Health Source Type: news
