“More than 40 people, the majority of them drug addicts, have died in eastern Pakistan after drinking a cough syrup believed to have been toxic, doctors and police officials said on Saturday……..Shaheen said chemical samples collected from the victims’ stomachs contained dextromethorphan, a synthetic morphine derivative used in cough syrup that can have mind-altering effects if consumed in large quantities.
Shaheen said it is being investigated whether the people affected by the syrup in Gujranwala drank too much of it, or whether there was a problem with the medicine itself…..”
“In November 2006, when Clara Marshall began suffering from the effects of dementia, her family moved her into……an assisted living home in Vancouver, Wash. The facility offered round-the-clock care for Ms. Marshall, who had wandered away from home several times………..
But just five months into her stay, Ms. Marshall, 81, was found dead in her room apparently strangled after getting her neck caught in side rails used to prevent her from rolling out of bed.
After Ms. Marshall’s death, her daughter Gloria Black, who lives in Portland, Ore., began writing to the Consumer Product Safety Commission and the Food and Drug Administration. What she discovered was that both agencies had known for more than a decade about deaths from bed rails but had done little to crack down on the companies that make them. Ms. Black conducted her own research and exchanged letters with local and state officials. Finally, a letter she wrote in 2010 to the federal consumer safety commission helped prompt a review of bed rail deaths……”
“Cathy Literski could tell something was wrong just from her mother’s voice on the telephone.
Her mother had learned that a steroid drug injected into her spine for back pain might have been contaminated with a fungus that could cause meningitis. Mrs. Literski had recently had the same type of injections herself, at the same pain clinic in Brighton, Mich. ……….“I think we’re both terrified that the other one is going to come down with it,” Mrs. Literski, 57, said. “She’s worried sick about me, and I’m worried sick about her………..
It will be weeks, maybe even months, before the two women know if they are in the clear, past the incubation period for this type of meningitis, which can cause strokes.
About 14,000 people in the United States are in the same nerve-racking situation: knowing they might have been infected, waiting to see if they get sick. So far, 282 have contracted meningitis, and 23 have died……… A few other patients have developed joint infections from having the drug, methylprednisolone, injected into knees, hips, shoulders or elbows…….”
Lead Levels In Lipstick Much Higher Than Previously Thought
15 Feb 2012
“A recent study conducted by the U.S Food And Drug Administration (FDA) reveals that over 400 popular lipstick brands contain twice as much lead as previously believed – up to 7.19 parts per million (ppm). …..Currently, the FDA website claims there is not a safety concern in the amount of lead found in lipstick. Their website says:
“We have assessed the potential for harm to consumers from use of lipstick containing lead at the levels found in both rounds of testing. Lipstick, as a product intended for topical use with limited absorption, is ingested only in very small quantities. We do not consider the lead levels we found in the lipsticks to be a safety concern. The lead levels we found are within the limits recommended by other public health authorities for lead in cosmetics, including lipstick.”
The U.S Centers for Disease Control and Prevention issued an announcement in January stating no amount of lead is a safe one, and they urge people to be diligent in stopping women who are pregnant and children from being exposed to it. …….”
Health Fears Over Suspect French Breast Implants Spread Abroad
By MAÏA de la BAUME and DAVID JOLLY
PARIS — “Health officials in at least a half-dozen countries are grappling with the intense anxiety of tens of thousands of women who received breast implants that were made in France with substandard silicone — and that have been rupturing at unusually high rates.
It is unclear whether there are health risks posed by the substandard silicone used in the implants, and the French government is expected to decide soon whether to require as many as 30,000 women in France to have their implants removed.
If the government mandates the removals, it will also pay for the procedures, though not for replacements……Tens of thousands more in other countries have had the company’s devices implanted, because PIP exported 80 percent of its products, many of them to Britain, Spain and Latin America. …….”
For Immediate Release: Jan. 13, 2011 Media Inquiries: Doug Karas, 301-796-2805, Douglas.Karas@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
FDA seeks to halt processing, distribution at New York juice company Company’s failure to correct violations prompts court action
At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products.
Hank J. Hagen and Milton S. Reid and their company, Mystical One LLC (also known as Mystical One Juice LLC), are charged with violating the Federal Food, Drug, and Cosmetic Act by failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as the company’s carrot juice products, and by failing to comply with current Good Manufacturing Practice (cGMP).
The FDA requires all juice processors to prepare and implement HACCP plans that identify and control food hazards associated with their juices, and it requires all food manufacturers to follow cGMP. The FDA is not aware of illnesses associated with Mystical One’s juice products.
Among the violations observed by FDA investigators were failures to:
• adequately heat low-acid vegetable juices to destroy or prevent growth of dangerous microorganisms;
• properly clean food-contact surfaces; and
• maintain and monitor sanitation conditions at the manufacturing facility to prevent sources of possible food and water contamination.
Failure to identify and control food hazards could lead to the formation of Clostridium botulinum bacteria that can germinate in the carrot juice made by the company. The neurotoxin formed by these bacteria, when ingested in even very small amounts, could cause paralysis, difficulty breathing and death from asphyxiation. In 2006, six cases of botulism in the United States and Canada were linked to refrigerated carrot juice.
The complaint also charges Mystical One, Hagen and Reid with failing to conform to cGMP requirements for making, packing, or holding human food. Beverage products produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act.
Violations cited by the FDA involved the following brands:
• Fresh Carrot Juice,
• Magnum Food Drink,
• Pineapple Ginger Drink,
• Sorrel & Ginger,
• Sea Moss, and
• Peanut Punch.
The company purchases ingredients, such as carrots, that originate outside of New York and sells products to food service establishments primarily in New York, Connecticut, and Pennsylvania.
The FDA’s most recent inspection at the Mystical One facility in August 2010 found the same or similar violations observed during previous inspections of the company. The agency issued a warning letter to the company in October 2009 and the company agreed to bring its operations into compliance. However, Mystical One did not make the necessary changes.
“This action shows that FDA will take strong enforcement action against companies that fail to put the required preventive controls in place to protect their customers from foodborne illness,” said Associate Commissioner for Regulatory Affairs Dara A. Corrigan. “Mystical One failed to adhere to food safety guidelines and we have stopped their operation.”
The injunction was filed by the Office of Loretta E. Lynch, United States Attorney for the Eastern District of New York, together with the Department of Justice’s Office of Consumer Litigation.
“….According to the most recent estimates from the Consumer Product Safety Commission, there are more than 590 finger amputations and 5,700 hospitalizations resulting from snow blowers each year, which mainly occur when people using the equipment fail to stop the engine before attempting to clear snow and debris from the machine…..”
CPSC offers the following safety tips for using snow throwers:
Stop the engine and use a long stick to unclog wet snow and debris from the machine. Do not use your hands to unclog a snow thrower.
Always keep hands and feet away from all moving parts.
Never leave the machine running in an enclosed area.
Add fuel to the tank outdoors before starting the machine; don’t add gasoline to a running or hot engine. Always keep the gasoline can capped, and store gasoline out of the house and away from ignition sources.
If you have an electric-powered snow thrower, be aware of where the power cord is at all times.
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico
No other Abbott Diabetes Care products are affected
More information is available at: www.precisionoptiuminfo.com
Abbott Diabetes Care Customer Service
(800) 448-5234 (English)
(800) 709-7010 (Espanol) Media Contact:
(510) 502-7076 FOR IMMEDIATE RELEASE – ALAMEDA, Calif. December 22, 2010 — Abbott Diabetes Care today announced that it has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico.
The test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled and customers can continue to use the blood glucose monitors.
The affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading. The problem appears to be related to longer than expected blood fill times. This may be dependent on the age of the strips and if the strips have been stored in (or exposed to) higher temperatures (above 72°F and not to exceed 86°F) for an extended period of time.
Customers who have test strips from these affected lots should discontinue use of the product. Abbott Diabetes Care will replace affected test strips at no charge. Abbott Diabetes Care initiated this recall following a routine internal quality review that indicated certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test strips may experience longer than normal blood fill times which may cause falsely low blood glucose readings.
Customers are advised to contact their health care provider to determine testing options if they do not have any unaffected test strips to use.
However, if consumers must use affected test strips while in the process of obtaining new strips, they should:
1. Check the amount of time it takes for their blood glucose meter to start the “countdown” after they first apply blood to the test strip. They should start timing immediately after blood first makes contact with the test strip. If the meter takes longer than five seconds to start the countdown, that test strip is affected and the result should not be used. Users should check the time for each test strip they use because all of the strips in a package may not be affected to the same degree. If any reading appears lower than they would expect or does not seem to correlate with the way they are feeling, the user should contact their health care provider immediately.
2. If they do not immediately have access to unaffected strips and are unable to test their blood sugar, users need to be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).
• Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If a user is experiencing any of these symptoms or is not feeling well, they should contact their health care professional immediately.
• Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If a user is unable to obtain unaffected strips, they should contact their health care provider for advice on how to treat these symptoms before they occur.
The recommendation is that hospitals and user facilities stop using the recalled test strips and follow the steps below:
1. Use test strips from unaffected lots.
2. If the health care facility does not have any test strips from unaffected lots but has an alternative point-of-care blood glucose testing system, begin using the alternative system until new, unaffected test strips can be obtained.
3. If the health care facility does not have any test strips from unaffected lots or immediate access to an alternative point-of-care blood glucose testing system, health care providers should take the following steps:
• Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Monitoring System using a central laboratory blood glucose method. Clinical judgment should be applied when deciding whether to act on results prior to verification.
• Verify any Precision Xceed Pro Blood Glucose Monitoring System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
• Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five seconds, discard that test strip immediately to prevent the risk of receiving a falsely low blood glucose result (if this occurs, health care providers should note the lot number of that test strip, discard all the test strips from that lot, and notify Abbott Diabetes Care immediately).
Customers can check if they have test strips from the affected lots by visiting www.precisionoptiuminfo.com and looking up their product lot number.
Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima customers can also get information by calling Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español).
The website and customer service phone numbers listed above will also provide customers with information about returning affected test strips.
Unaffected Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strip lots may be used by customers to test their blood glucose as directed by their health care providers.
Abbott Diabetes Care has reported this situation to the U.S. Food and Drug Administration and is working to make the necessary corrective actions to prevent this situation from recurring.
FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or Entertainment
Date Issued: Dec. 16, 2010
Product: Hand-held laser pointers that emit 5 milliwatts (mW) output power or higher.
Purpose: The Food and Drug Administration (FDA) is alerting consumers about the risk of eye and skin injuries from high-powered laser pointers.
Summary of Problem and Scope:
The Food and Drug Administration (FDA) is alerting consumers about the risk of eye and skin injuries from exposure to high-powered laser pointers. FDA regulations limit the energy output of hand-held laser pointers to 5 milliwatts (mW).
Although illegal and potentially dangerous, they are increasingly available on the Internet and in stores. The FDA wants to make consumers aware that they should not buy these lasers for themselves or as gifts for others.
Even at the 5mW legal limit, when lasers are aimed directly into the eye, they will cause temporary flash blindness. This will not likely cause permanent injury, because most people have a protective reflex to look away, blink, or make other involuntary movements to protect the eyes. However, reflections of the laser beam from mirrors or metallic surfaces may not induce the protective reflex quickly enough to avoid injury, and intentionally keeping your eyes open and staring into a 5 mW beam will cause eye injury.
Lasers that emit more than 5mW output power can cause irreversible eye injury of increasing severity with increased output power. These high-powered laser pointers can irritate or even burn the skin.
The FDA believes that many eye injuries from laser pointers go unreported. Nonetheless, the FDA is aware of laser pointer radiation incidents involving military personnel, researchers, and public speakers. The number of eye injuries in children resulting from playing with laser pointers is increasing. The FDA is aware of three incidents reported in the media among children in 2010.
The FDA is also aware of incidents reported by the Federal Aviation Administration of pilots experiencing temporary flash-blinding when lasers are aimed at their aircraft. The temporary loss of vision reported by pilots during these incidents could cause a serious accident. In 2009, pilots reported a total of 1500 incidents of light beams striking their aircrafts or illuminating their cockpits, the majority of which were from laser light. In the first 10 months of 2010, 2321 incidents were reported. Using a laser to illuminate aircraft is a federal crime. Individuals convicted of shining either legal or overpowered lasers on an aircraft are subject to fines and may be sentenced to prison time due to the seriousness of such crimes.
Other incidents that the FDA is aware of include:
A child’s eyes were damaged from reflected beams after directing a150 mW laser pointer into a mirror.
A California man was convicted and sentenced to 15 months in federal prison for shining a laser pointer at a police helicopter, causing the pilot to suddenly look away and change direction.
In its August 2010 press release, the Laser Institute of America warned the public of the hazards of relatively inexpensive 1000 mW blue lasers (995 mW over the legal limit) available from an internet retailer. As high-powered laser pointers become more affordable their availability increases along with the chance that injuries will occur.
The FDA regulates laser product manufacturers and sets performance standards for lasers to protect the public from laser radiation. The sale of lasers which do not meet these standards is illegal in the United States. Domestic and foreign laser manufacturers are subject to FDA inspections or targeted investigations to identify unsafe or non-compliant laser products. Laser products imported into the U.S. are inspected by U.S. Customs and Border Protection with FDA cooperation.
Manufacturers that fail to comply with FDA’s requirements are subject to regulatory action. Regulatory actions may include requiring recalls of unsafe products or detaining such products upon import to the U.S. For example, several foreign manufacturers produce and sell laser pointers with an output greater than 5mW and have been placed on Import Alert, which identifies their products for automatic detention by FDA when they enter the U.S. Some foreign manufacturers attempt to avoid U.S. Customs and FDA oversight, but FDA continues to conduct various actions to prevent the entry of illegal laser products into the U.S.
The FDA recognizes that there are varied and legitimate uses of laser pointers, including giving presentations, aligning and leveling in construction, providing gun sights, and pointing to stars. Even lasers under the 5mW limit can cause harm if not used properly. The FDA recommends the following:
Do NOT buy laser pointers for children or allow them to use them. These products are not toys.
Do NOT buy any laser pointer that emits more than 5 mW output power and does not have the output power printed on the warning label affixed to the pointer. Hand-held laser pointers over 5 mW and those that are not properly labeled are illegal and potentially dangerous.
Do NOT aim or shine laser pointers at any person, pet, vehicle, or aircraft directly, or through reflection by mirrors or other shiny surfaces.
Check the output power of any laser pointer that you own. If it has an output greater than 5 mW, dispose of it safely according to local environmental protection guidelines.
In the event of injury, immediately consult your eye doctor.
Report Problems to FDA:
Prompt reporting of injuries can help FDA identify and lessen the risks associated with these products. If you have been injured by a laser pointer, or if you witness an injury involving a laser pointer, we encourage you to submit a report to the FDA District Office consumer complaint coordinator for your geographic area.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.