Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, Velextra brand SKU’s 626570619475, 626570619475, 626570619475, 626570619475 , Amerect SKU’s 626570619031, 626570619598 capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.
Chang Kwung Issues A Voluntary Nationwide Recall of Lightning Rod Capsules Due to Undeclared Ingredient
2013 Chang Kwung announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand name Lightning Rod 500 mg per capsule packaged in 3-count, UPC 6 89076 20257 2 and 12-count bottles, UPC 6 89076 20297 8.
Chang Kwung is conducting a voluntary recall after being notified by the US FDA that analytical testing found the Lightning Rod Capsules to contain an analogue of Sildenafil.
FDA issues proposal to increase consumer awareness of tanning bed risks
Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
FDA warns pregnant women to not use certain migraine prevention medicines
The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Cargill’s Animal Nutrition Business Conducts Voluntary Recall of Lamb Feed
Cargill’s animal nutrition business today announced a voluntary recall of Showmaster® S-Series Show Lamb Feed (BW) because it contained incorrect sodium molybdate levels. To date, there are 170, 50-pound bags of feed still out in the market.
Nestle USA Announces Voluntary Recall of Select Varieties/Production Codes of California Pizza Kitchen and DiGiorno Frozen Pizzas
Nestlé USA’s Pizza Division today announced the voluntary recall of select production codes of four different frozen pizzas sold in the U.S. These include:
• California Pizza Kitchen (CPK) Crispy Thin Crust White®, UPC 71921 98745; production codes are 3062525951, 3062525952 and 3063525951.
Medtronic Announces FDA Classification Of Deep Brain Stimulation Lead Cap Communication
In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc. (NYSE: MDT) issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation (DBS) lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits.
American Lifestyle Issues a Worldwide Voluntary Recall of Vicerex Capsules and Black Ant Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients
May 1, 2013 – American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil.
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
FDA approves Procysbi for rare genetic condition
The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.