The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
Category Archives: Food & Drug Recalls
Karoun Dairies, Inc. Issues Nationwide Voluntary Recall of Various Cheeses Because of Possible Health Risk
Today Karoun Dairies, Inc. announced that it is voluntarily recalling a variety of cheeses it distributes due to possible contamination with Listeria monocytogenes. To date, no product has tested positive for Listeria but in view of the association with listeriosis cases Karoun Dairies Inc. is initiating a voluntary recall in the interest of protecting public health.
Thoratec Issues Voluntary Device Correction
Thoratec Corporation (NASDAQ: THOR) today issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.
Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa
Iowa Select Herbs, LLC (the “Company”) is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated.
Potential Health Hazard: Recalled Snack Fresh Brand Red Apple Slices May Have Been Distributed To Florida’s Palm Beach County School District
Appeeling Fruit Inc. in Dauberville, Penn. has been informed by one of its customers that some of the Snack Fresh brand, 2 oz. bagged red apple slices with Best-if-Used-by date 09/21/15 and production date 310815 that was voluntarily recalled on Wednesday, September 9 due to the potential of being contaminated with listeria monocytogenes may have been distributed to schools in Florida’s Palm Beach County School District (product photo is available at www.appeelingfruit.com). Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA issues orders that will stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products
Today the U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products – including its Camel Crush Bold brand – because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Limited Precautionary Recall of 5 oz organicgirl Baby Spinach Announced
organicgirl Produce is voluntarily recalling a limited quantity of 5 oz. organicgirl Baby Spinach with a Use-by Date of September 13 and Product Code B030298-001B08S due to test results indicating the presence of trace levels of the naturally-occurring element cadmium. The recall includes 1,290 cases distributed primarily to Western and Midwestern states.
Custom Prodouce Sales Voluntarily Recalls Fat Boy Brand® and Unlabeled Cucumbers Because of Possible Health Risk
Custom Produce Sales (“Custom Produce”) of Parlier, California is voluntarily recalling all cucumbers sold under the Fat Boy® label starting August 1, 2015 because they may be contaminated with Salmonella and are covered by an ongoing recall. No other Fat Boy® products are covered by this recall.
Custom Produce Sales Voluntarily Recalls Fat Boy Brand® and Unlabeled Cucumbers Because of Possible Health Risk
Custom Produce Sales (“Custom Produce”) of Parlier, California is voluntarily recalling all cucumbers sold under the Fat Boy® label starting August 1, 2015 because they may be contaminated with Salmonella and are covered by an ongoing recall. No other Fat Boy® products are covered by this recall.
The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence of Undeclared Phenolphthalein and MIRACLE ROCK 48 Due to Presence of Undeclared Thiosildenafil
September 11, 2015 — North Miami Beach, Florida — The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.