Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
Category Archives: Food Safety News
FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
Evershing International Trading Issues Allergy Alert on Undeclared Milk in Vinacafe Brand Coffee – Wake Up Weasel Instant Coffee mix 3-in-1
Evershing International Trading is voluntarily recalling Vinacafe Brand Wake Up Weasel Instant Coffee mix 3-in-1 after learning that the product may contain Sodium Caseinate ( a Milk derivative), a Milk allergen, and Soy extract, a Soy Allergen, that is not declared on the products’ ingredient statement. People who have an allergy or severe sensitivity to Milk and/or Soy have the risk of serious or life-threatening allergic reaction if they consume this coffee.
Read The Complete Story!
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Lundberg Family Farms Recalls Eco-Farmed and Organic Brown Rice Flour Because of Possible Health Risk
Lundberg Family Farms announced that it is voluntarily recalling specific bags of Brown Rice Flour because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Read The Complete Story!
Oasis Brands, Inc. Retira Productos Lacteos Santa Martha debido a Posible de Riesgos a la Salud
Oasis Brands, Inc. de Miami, FL está retirando lotes selectos de productos Lácteos Santa Martha con fechas de vencimiento de 07/01/14 al 12/31/14, debido a que los productos tienen el potencial de estar contaminados con Listeria monocytogenes, un organismo que puede causar infecciones serias y a veces fatales en jóvenes, niños, personas débiles o ancianas, y otros con sistemas inmunológicos debilitados. Aunque individuos sanos pueden sufrir sólo síntomas a corto plazo, tales como fiebre alta, dolor de cabeza severo, rigidez, náuseas, dolor abdominal y diarrea, la infección de Listeria puede causar abortos involuntarios y mortinatos among pregnant women.entre las mujeres embarazadas.
Read The Complete Story!
New Jersey Firm Issues Allergy Alert on Undeclared Fish, Wheat and Egg In Garden Rotini Salad
Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling 1,510 units of WAWA Garden Rotini Salad due to the potential of undeclared fish, wheat and egg allergens contained in the salad.
Read The Complete Story!
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Lundberg Family Farms Recalls Sea Salt Rice Chips Due to Undeclared Allergen
Lundberg Family Farms announced that it is voluntarily recalling from distribution in the United States and Canada, specific bags of Sea Salt Rice Chips due to possible presence of an undeclared dairy allergen. The issue was discovered through a consumer complaint.
Read The Complete Story!