This FDA bulletin for health professionals rounds up recalls of Cook Medical's CloverSnare vascular retrieval snare and, as a Class I recall, Cardiovascular Systems' Diamondback 360 atherectomy sheaths, plus 73 products with July prescribing-information revisions.
Section archive
Page 3 of 13
Government
Updates from the FDA, CDC and other agencies.
- All desks
- Abortion
- Accutane
- Acetaminophen
- Acid Reflux
- Acidic Foods
- Acne
- Acrylamide
- Acupuncture
- Additives
- ADHD
- Adiposity
- Advisories
- Aerobic Exercise
- Aflatoxin
- Agave
- Agent Orange
- Aging
- Agriculture
- AIDS
- Air Pollution
- Airline Passengers
- Airport
- ALA
- Alcohol
- Alcoholic Beverage
- Alerts
- Allergy
- Alli
- Aloe Vera
- ALS
- Alternative Medicine
- Aluminum
- Alzheimer's
- Amalgam
- AMD
- Ampyra
- Amygdala
- Anal Cancer
- And
- Anemia
- Angiogenesis
- Animal Protein
- Animals
- Anorexia
- Anthocyanins
- Anthrax
- Anti-Angiogenesis
- Anti-Obesity
- Antibacterial
- Antibiotic
Government
WANTED: Consumers to Report Problems - FDA
The FDA asks consumers to report problems with drugs, supplements, infant formula, cosmetics, medical devices, biologics and food through its MedWatch form, noting that reports can prompt label changes, safety messages or removal of a product from the market.
Government
Turkish man guilty to importing illegal cancer drugs
Sabahaddin Akman, owner of Turkey's Ozay Pharmaceuticals, pleaded guilty to importing misbranded and adulterated cancer drugs, chiefly Altuzan, an unapproved Turkish version of Avastin. FDA says he disguised shipments as gifts and split them into small packages.
Government
FDA Updates for Health Professionals - 08-13-2014
An FDA roundup for health professionals covers the recall of Cubicin injection vials over possible glass particulate and a Class I recall of IPM Wound Gel for bacterial contamination, plus MedWatch reporting resources and an August 28 webinar.
Government
FDA warns consumers not to use certain tattoo inks and tattoo kits sold online
FDA confirmed bacterial contamination in unopened White and Blue Lion tattoo inks and in needles from its kits, recalled July 11, 2014. The agency has one report of skin infection and warns that similarly packaged inks remain on sale online.
Government
FDA: Inks Used in Certain Tattoo Kits Cause Infections
FDA confirmed bacterial contamination in unopened bottles of tattoo ink from home kits marketed by White and Blue Lion, and one skin infection in a consumer who used them. The agency warns infections can scar permanently or spread through the bloodstream.
Government
Mom, Can I Get Contact Lenses, Please?
FDA optometrist Bernard Lepri weighs contact lenses for children: they resist breakage in sports and can sharpen vision in very nearsighted kids, and one Ohio State study found better self-perception. He stresses they are medical devices needing supervision and responsible use.
Government
2014 State Sales Tax Holidays
Many states drop sales tax for a few days, often the first weekend of August, on clothing, computers, footwear and school supplies, subject to per-item price caps. The listing gives each state's dates, qualifying items, maximum costs and revenue department links.
Government
Cord Blood: What You Need to Know
FDA approves cord blood only for hematopoietic stem cell transplantation, used in patients with blood cancers such as leukemia and disorders like sickle cell disease. Keith Wonnacott says collection after the cord is cut is generally safe, but warns that stem cell fraud cases exist.
Government
FDA Updates for Health Professionals - 07-30-14
An FDA bulletin for health professionals summarizes recent safety items, among them a Class I recall of GE Healthcare airway modules whose CO2 detectors may fail or report wrong values, and a labeling-error recall of Advocate Redi-Code+ blood glucose test strips.
Government
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
FDA Commissioner Margaret Hamburg backs the Surgeon General's Call to Action on skin cancer and lists FDA's steps: 2011 sunscreen labeling changes covering Broad Spectrum and water-resistance claims, and a new risk classification for sunlamps requiring boxed warnings against use under 18.
Government
H.R.4250 - Sunscreen Innovation Act 113th Congress (2013-2014)
The Sunscreen Innovation Act would create an FDA process for reviewing over-the-counter sunscreens, making ingredients marketed for five continuous years eligible, setting review deadlines, and requiring decisions on aerosol sunscreens and SPF labels above 50.
Government
Providing Quality Family Planning Services - A CDC report
CDC and the HHS Office of Population Affairs set out joint recommendations for quality family planning services, covering contraception, pregnancy testing and counseling, help achieving pregnancy, basic infertility care, preconception health and STD services, aimed at all such providers.
Government
FDA Updates for Health Professionals - 07/16/14
The FDA's Office of Health and Constituent Affairs rounds up July 2014 items for clinicians: 52 products with prescribing-information changes, a warning against drugs from Unique Pharmaceuticals over sterility, a Hospira lactated Ringer's lot recalled for mold, and weight-loss alerts.
Government
Hurricane Season: Be Prepared
FDA's Yinqing Ma advises keeping crops, food and drinking water clear of flood water, which may carry sewage, chemicals, heavy metals or pathogens. Discard food that was not in a waterproof container, any damaged cans, and perishables held above 40 degrees for two hours or more.
Government
FDA warns health care professionals not to use injectable vitamin products distributed by Medical Supply Liquidators with a Sunshine Labs label
FDA is telling health care professionals not to use injectable vitamin products distributed by Medical Supply Liquidators of Clive, Iowa under a Sunshine Labs label. Made in the Dominican Republic and never FDA approved, all non-expired lots are being recalled; no adverse events are known.
Government
FDA: Risks of Decorative Contact Lenses
The FDA, the American Optometric Association and the Entertainment Industries Council released public service videos, one using clips from “American Horror Story,” warning that decorative contact lenses worn without an eye exam and prescription risk infection and blindness.
Government
FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning
FDA warns that prescription oral viscous lidocaine 2 percent should not be used for teething pain and is adding a Boxed Warning. In 2014 it reviewed 22 reports of serious harm, including deaths, in children given the solution or who swallowed too much.
223 stories