The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.
Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack
Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.
Bakers of Paris Recalls Croissants Sold at Whole Foods Market® Stores in Northern California Due to Undeclared Allergen
Bakers of Paris (Brisbane California), is recalling plain and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list.
Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
Cary, IL, Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.
Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016.
Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016.
Oriental Packing Co., Inc. Issues Alert on Lead in Curry Powder
Oriental Packing Co., Inc., Miami, Florida is recalling approximately 377,000 lbs. of the following blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences
Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk
Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.
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Rabbit Creek Products recalls certain flavors of bread, muffin and brownie mixes because of a possible health risk
Rabbit Creek Products of Louisburg, KS is recalling certain flavors of Bread mixes, Muffin mixes and Brownie mixes under the Rabbit Creek Products and other Private label brand names due to the potential presence of Escherichia coli O:121 (E. coli O:121). People usually get sick from E. coli O: 121, also referred to as STEC O:121, 2-8 days (average of 3-4 days) after swallowing the bacteria. Most people develop diarrhea (often bloody) and abdominal cramps.
FDA updates draft guidance on premarket safety notifications for dietary supplement industry
The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.