We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined.
Category Archives: Food & Drug Recalls
FDA proposes lower risk classification for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA proposes lower risk classification, guidance for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis. This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA approves first generic Lexapro to treat depression and anxiety disorder
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.
Publix Issues Allergy Alert On Publix Beef Stew Mix
McCormick & Company, Inc. has notified Publix Super
Markets of a voluntary recall for a single lot code of Publix Beef Stew Mix because it may be
mispacked with brown gravy and may contain undeclared milk. People who have an allergy
or severe sensitivity to milk run the risk of allergic reaction if they consume this product.
La FDA aprueba nuevos implantes de seno rellenos de gel de silicona
La Administración de Alimentos y Drogas de los Estados Unidos (FDA) aprobó hoy los implantes de seno rellenos de gel de silicona fabricados por Sientra Inc. para aumentar el tamaño del seno (aumentación) en las mujeres por lo menos 22 años de edad y para reconstruir el tejido de los senos (reconstrucción) en las mujeres de cualquier edad.
FDA approves new silicone gel-filled breast implant
Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
FDA approves first cell-based product to treat oral mucogingival conditions in adults
The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
Cargill Animal Nutrition Conducts Regional Recall of Nutrena NatureWise Goat Pellets
Cargill Animal Nutrition today announced a voluntary and limited regional recall of Nutrena NatureWise Goat Pellets due to an error in labeling. The bags of affected goat feed should have indicated that the feed included Decoquinate, a medicated article for the prevention of coccidiossis that is commonly included in ruminant feed, but which is not approved for lactating goats.
Gerber Voluntarily Withdraws a Specific Batch of Gerber Good Start Infant Formula and Offers Replacement Product to Consumers
Gerber Products Company is proactively retrieving and offering a replacement to consumers who purchased Gerber Good Start Gentle powdered infant formula 23.2 ounce plastic package from batch GXP1684 expiration date of March 5, 2013. The product poses no health or safety risk.