News for August, 2009

Barr recalls oversized ADHD, narcolepsy drugs

barr labs logoA medication used to treat narcolepsy and attention deficit hyperactivity (ADHD) in adults and children is being recalled by the manufacturer because some of the tablets exceed weight requirements, which could make them super-potent and could pose a risk to consumers who take them.

The recall, announced by the Food and Drug Administration (FDA) includes Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (mixed salts of a single entity amphetamine product) 20 mg tablets, 100-count bottles, lot number 311756. The recalled lot, made by Barr Laboratories, Inc., was distributed between June 6, 2009 and June 16, 2009.

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Guilty pleas for company, owners who distributed tainted pet food

pet foodA Nevada-based company and its owners pleaded guilty in federal court this week to distributing a contaminated ingredient used to make pet food, according to Online Montgomery. That tainted substance was linked to the deaths and serious illnesses of countless pets throughout the country, and resulted in a nationwide recall of pet food.

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New CPSIA requirements for children’s products go into effect today

The U.S. Consumer Product Commission (CPSC) announced that new requirements of the Consumer Product Improvement Act (CPSIA) would go into effect today. The new regulations are aimed at making children’s products safer and increasing consumer confidence in the marketplace. The new requirements will affect product manufacturing standards, toughen regulations about advertising children’s products, and increase fines for violations of these standards.

CPSC Chairman Inez Tenenbaum said, “I will ensure that these requirements are enforced vigorously and fairly.” She urged businesses to comply.

New standards include:

  • The limit for Lead Content in children’s products will be reduced from 600 parts per million to 300 parts per million.
  • The limit for Lead in Paint and Similar Surface Coating Materials in children’s products also will be lowered significantly, from 600 parts per million to 90 parts per million.
  • The Civil Penalties for violation of CPSC standards involving children’s products will be substantially increased.
  • Manufacturers will be required to place Tracking Labels on consumer products intended primarily for children.
  • Catalog Advertising for certain toys and games intended for use by young children (ages 3-6) must have stricter warnings of potential dangers.

Tenenbaum says, “By ensuring that toys and other children’s products meet strict lead limits and can be tracked in the event of a recall, I believe children will be better protected in their homes.”

For more information, visit the CPSC web site.

FDA sends warning about glucose test strips

glucose test strips 150 100x100The Food and Drug Administration (FDA) is issuing a warning to diabetes health care professionals, hospital risk managers and patients about a brand of glucose test strips that may falsely report elevated blood glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or .

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Wii Battery Recharge Stations recalled; pose burn or fire hazard risk

WII 100x100Wii Battery Recharge Stations have been recalled by distributor Griffin International Cos., Inc. because the battery packs can overheat, posing a burn or fire hazard to the customer, according to an announcement by the U.S. Consumer Product Safety Commission (CSPC). Consumers with Psyclone Essentials or React Wii 4-Dock Battery Recharge Stations should stop using the recalled products immediately.

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Illinois mom says negligence led to her son’s brain injuries

flyers 100x100It’s a fact of life. When kids play contact sports, injuries can occur. The risk of becoming injured is why athletes – whether they’re professional baseball players or high school football players – don protective gear. Nothing, of course, completely eliminates the risk of injury, but wearing protective gear greatly diminishes it.

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FDA recalls infusion pumps; risk of serious injury, death

infusion pumpElectronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural and other routes of administration are being pulled from the market after the Food and Drug Administration (FDA) issued a Class 1 recall on the products. A Class 1 recall is the most serious type of recall and involves situations in which there is reasonable probability that the use of the products will cause serious injury or .

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Arthritis drugs increase risk of cancer among children

juvenile arthritisThe Food and Drug Administration (FDA) is requiring a group of popular arthritis drugs to include stronger warning of the increased risk of lymphoma and other cancers in children and adolescents treated with the medication. The warning, which follows an analysis by the FDA of tumor necrosis factor (TNF) blockers, will now be added to the black box warning currently on the products.

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Botox receives FDA black box warning

botox injection 100x100Manufacturers of licensed botulinum toxin (Botox) are now required by the Food and Drug Administration (FDA) to strengthen warnings on its product labeling and add a black box warning – the strongest warning the agency can require – of risk of adverse events when the effects of the toxin spread beyond the site where it was injected. Notice of the label update was issued this week by the FDA to cosmetic surgeons, neurologists and consumers.

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Black & Decker re-issues trimmer-edger recall

B&D weedeater2Black & Decker, Inc. of Towson, Maryland, and the U.S. Consumer Products Commission have re-announced a recall of approximately 200,000 defective Grasshog XP Trimmer/Edgers (weed whackers, weed eaters) due to the risk of laceration and burn hazards they pose.

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