Latest Fda Approved Drugs Information Systems

Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.

Euphoria Fancy Food Inc. at 149-151 2nd Ave. Brooklyn NY 11215 is recalling DRIED BREAM discovered by New York State Department of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of product by Food Laboratory personnel confirming that the fish was not properly eviscerated prior to processing. This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness.

June 18, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Abacavir Sulfate abacavir sulfate Tablet; Oral Mylan Pharms Inc Approval Modicon 28 ethinyl estradiol; norethindrone Tablet; Oral-28 Janssen Pharms Labeling Revision Ortho Cyclen-21 ethinyl estradiol; norgestimate Tablet; Oral-21 Janssen Pharms Labeling Revision Ortho Cyclen-28 ethinyl estradiol; norgestimate Tablet; Oral-28 Janssen Pharms Labeling Revision Ortho Tri-Cyclen ethinyl estradiol; norgestimate Tablet; Oral-21 Janssen Pharms Labeling Revision Ortho Tri-Cyclen ethinyl estradiol; norgestimate Tablet; Oral-28 Janssen Pharms Labeling Revision Ortho Tri-Cyclen Lo ethinyl estradiol; norgestimate Tablet; Oral-28 Janssen Pharms Labeling Revision Ortho-Cept desogestrel; ethinyl estradiol Tablet; Oral-21 Janssen Pharms Labeling Revision Ortho-Cept desogestrel; ethinyl estradiol Tablet; Oral-28 Janssen Pharms Labeling Revision Ortho-Novum 1/35-28 ethinyl estradiol; norethindrone Tablet; O

June 19, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Helidac bismuth subsalicylate; metronidazole; tetracycline hydrochloride Tablet, Chewable, Tablet, Capsule; Oral Prometheus Labs Labeling Revision Helidac bismuth subsalicylate; metronidazole; tetracycline hydrochloride Tablet, Chewable, Tablet, Capsule; Oral Prometheus Labs Manufacturing Change or Addition Olanzapine; Fluoxetine Hydrochloride olanzapine; fluoxetine hydrochloride Capsule; Oral Teva Pharms Approval Sumatriptan Succinate sumatriptan succinate Tablet; Oral Apotex Inc Approval

Leasa Industries Co., Inc. of Miami, FL is recalling 433 cases of LEASA Living Alfalfa Sprouts with use by date 7/2/12, because it has the potential to be contaminated with Salmonella. The affected product is in 6 oz. clear plastic containers with a UPC code of 75465-55912 and has an expiration date of 7/2/12.

ISSUE : Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death. Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010. BACKGROUND : Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting. RECOMMENDATION : The firm sent its distributors a Field Correction notice May 1, 2012, asking distributors to contact customers and/or patients who brought these products. Consumers should notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's

June 13, 2012 — Working in a real hospital isn’t usually as dramatic as is portrayed in TV shows like  Grey’s Anatomy  or  House, MD , but a  new study  has identified unprofessional behaviors to which hospital-based doctors most frequently admit, including badmouthing fellow doctors and finding medical excuses to get out of having to care for patients. Two-thirds of doctors surveyed at three Chicago hospitals copped to having personal conversations, such as discussing evening plans, in earshot of patients, and 62 percent said they had mischaracterized a routine test as “urgent” to get it done faster. Four out of 10 said they mocked another physician to colleagues. The same number said they bad-mouthed emergency room doctors for missing part of a patient’s medical problems. Three out of 10 said they made disparaging comments about a patient on rounds. Twenty-nine percent said they had attended a dinner or social event sponsored by a drug or medical device manufacturer or other b