Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething viagra cialis online pharmacy pharmacy to Address Manufacturing Process
Contact:
Mary C. Borneman
424-224-4135
FOR IMMEDIATE RELEASELos Angeles, October 23, 2010 - Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland's Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.
The Hyland’s Teething Tablets UPC codes included in the recall are:
1.Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2.Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3.Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4.Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5.Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6.Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
Adverse events have been reported but the FDA has said that a conclusive link to Teething Tablets has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.
After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.
In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.
Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall9 or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
"We initiated this voluntary recall to ensure our consumers know that their families' safety and health are our top priorities," said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. "We are committed to maintaining and deserving the trust they have placed in Hyland's. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust."
Hyland's Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.
Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch10.
With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit www.hylands.com11 or www.facebook.com/Hylands.Health.
About Standard Homeopathic Company
Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland's brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté, Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family.
Tuesday 1 November 2011
Saturday 29 October 2011
Good Tasting Medicine?
Good Tasting Medicine?
I went to pick up some medicine today, and this was the sign I saw in the online pharmacy viagra window.
WHAT?
No Way!
Medicine is supposed to taste bad...for at least two reasons.
The first is obvious: little kiddos are known for prying in places where they shouldn't, and, because of our genetic survivial of the fittest traits, they tend to taste unknown food/substances before eating. So, if the little miscreants get hold of mommy's and daddy's get happy pills, a bitter taste would prevent them from shooting them down the pipe.
The second reason for bad tasting medicine has to do with tradition: what would happen to the saying "Take your medicine" if the medicine tasted good? What would have happened to the delightful scenes in the movies when the parent threatened the kids with castor oil when they complained of a stomach ache to stay out of school? How much less poignanat would the scene have been if the little fakers said, "WHOO HOO, it's MEDICINE TIME!" instead of, "Oh, NO, please not the castor oil. I'm better. Really I am! I'm ready to go to school."
Also, we're not supposed to want to take medicine. After all, it's MEDICINE! You're not supposed to like the debt restructuring plan your bank gave you, but you do it because you know it's good for you and you want to get it over with.
Perish the thought of good tasting medicine. It just doesn't tase right.
Mike Sledge
I went to pick up some medicine today, and this was the sign I saw in the online pharmacy viagra window.
WHAT?
No Way!
Medicine is supposed to taste bad...for at least two reasons.
The first is obvious: little kiddos are known for prying in places where they shouldn't, and, because of our genetic survivial of the fittest traits, they tend to taste unknown food/substances before eating. So, if the little miscreants get hold of mommy's and daddy's get happy pills, a bitter taste would prevent them from shooting them down the pipe.
The second reason for bad tasting medicine has to do with tradition: what would happen to the saying "Take your medicine" if the medicine tasted good? What would have happened to the delightful scenes in the movies when the parent threatened the kids with castor oil when they complained of a stomach ache to stay out of school? How much less poignanat would the scene have been if the little fakers said, "WHOO HOO, it's MEDICINE TIME!" instead of, "Oh, NO, please not the castor oil. I'm better. Really I am! I'm ready to go to school."
Also, we're not supposed to want to take medicine. After all, it's MEDICINE! You're not supposed to like the debt restructuring plan your bank gave you, but you do it because you know it's good for you and you want to get it over with.
Perish the thought of good tasting medicine. It just doesn't tase right.
Mike Sledge
Tuesday 3 May 2011
Evidence Based Medicine, Medical Malpractice and Incentives
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A recent Dustin Comic like all good comics hit the proverbial nail on the head
Unfortunately the healthcare reform fails to address key aspects to the incentive problem in healthcare. The system remains centered on measuring what we do for patients rather than the end result.
There are moves by employers and the insurance industry to incentives patients towards healthier behavior. This approach is not without problems as highlighted in this piece in the New England Journal of Medicine "Carrots, Sticks, and Health Care Reform — Problems with Wellness Incentives" where the authors highlight the challenges for employers, employees and insurance in creating incentive and how this can introduce inequities that do more harm than good. As they point out
There are some initial moves in this direction and a need to implement technology to help guide the treatment (as we see with ICSI) and all this would also lead to higher quality of care for everyone and possibly a new system that reimbursed based on the quality of care delivered versus the quantity of care.
A recent Dustin Comic like all good comics hit the proverbial nail on the head
Unfortunately the healthcare reform fails to address key aspects to the incentive problem in healthcare. The system remains centered on measuring what we do for patients rather than the end result.
There are moves by employers and the insurance industry to incentives patients towards healthier behavior. This approach is not without problems as highlighted in this piece in the New England Journal of Medicine "Carrots, Sticks, and Health Care Reform — Problems with Wellness Incentives" where the authors highlight the challenges for employers, employees and insurance in creating incentive and how this can introduce inequities that do more harm than good. As they point out
If people could lose weight, stop smoking, or reduce cholesterol simply by deciding to do so, the analogy might be appropriate. But in that case, few would have had weight, smoking, or cholesterol problems in the first placeThere is no doubt that patient incentives must be part of the solution but require thoughtful design and implementation to avoid the pitfalls
Incentives for healthy behavior may be part of an effective national response to risk factors for chronic disease. Wrongly implemented, however, they can introduce substantial inequity into the health insurance system. It is a problem if the people who are less likely to benefit from the programs are those who may need them more.But incentives aligned to the practice of evidence based medicine and in particular the financial challenges facing the ever increasing ordering of tests is where there seems to be significant progress. The announcement of a statewide adoption of Radport by the Institute of Clinical Systems Improvement (ICSI), a nonprofit comprising 60 medical groups, 9,000 physicians, and six payers and health plans was covered extensively at RSNA 2010 in Chicago this year and featured in this piece in Information Week "System Helps Doctors Pick The Right Tests" demonstrating a saving of $27 Million over the preceding year
During the yearlong pilot involving more than 2,300 ICSI-member physicians, ICSI saw no growth in the number of high-tech diagnostic imaging tests ordered. In previous years, the number of tests ordered grew about 8% annually...The lack of growth translates to a savings about $28 million for the yearBut any discussion on incentives needs to include the issue of malpractice - liability drives behavior in the same way as incentives do (in some respects its incentive in another from). Peter Orszag opinion in the NY Times Malpractice Methodology makes the point that
The health care legislation that Congress enacted earlier this year, contrary to much of today’s overheated rhetoric, does many things right. But it does almost nothing to reform medical malpractice laws. Lawmakers missed an important opportunity to shield from malpractice liability any doctors who followed evidence-based guidelines in treating their patients.President Obama weighed in on this issue in June 2009 when he spoke to the American Medical Association when he highlighted the "unnecessary tests and treatments (ordered by doctors) only because they believe it will protect them from a lawsuit" and as he put it
We need to explore a range of ideas about how to put patient safety first, let doctors focus on practicing medicine and encourage broader use of evidence-based guidelinesMedicine remains "more evidence-free" than should be the case:
One estimate suggests that it takes 17 years on average to incorporate new research findings into widespread practiceAddressing the issue of liability can take the traditional approach of limiting punitive damages but as Peter Orszag said "provide safe harbor for doctors who follow evidence-based guidelines" is a much better idea and one that would sit well with patients and doctors alike (I'd be interested to hear from lawyers who agree or disagree on the merits of such an approach).
There are some initial moves in this direction and a need to implement technology to help guide the treatment (as we see with ICSI) and all this would also lead to higher quality of care for everyone and possibly a new system that reimbursed based on the quality of care delivered versus the quantity of care.
Cricket WC 2011: Huge security clampdown!
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DHAKA: The opening game of the World Cup Saturday sees a huge security operation swing into action designed to prevent any repeat of the deadly 2009 attack on the Sri Lankan team that still haunts the sport.
Around 20,000 members of Bangladesh's elite paramilitary force the Rapid Action Battalion and regular officers have been deployed in Dhaka for the first match, police spokesman M. Sohail told AFP.
"All cricket venues, airports, the nine official hotels and transport for all the teams and officials fall under our security blanket," Sohail said as India and Bangladesh prepared to open the event.
Memories are still fresh of the attack in Lahore in March 2009 when gunmen ambushed the team bus carrying Sri Lanka's Test squad in the Pakistani city of Lahore.
Eight people were killed and seven Sri Lankan players and their assistant coach injured.
The attack led to Pakistan's removal by the International Cricket Council (ICC) as a co-host of the World Cup.
The Federation of International Cricketers' Associations (FICA) in a statement on Friday said its security consultants -- Eastern Star International (ESI) -- had "found proposed security arrangements to be sound."
"ESI informed they were confident that provided the plans are implemented in a professional manner the risk to the players in this event will be minimised as far as possible," the Australia-based association added.
It said that security was "a massive challenge" with 14 teams moving around the co-hosts Bangladesh, Sri Lanka and India, South Asia's biggest country, which has a long history of militant violence.
Tim May, the FICA chief executive, said security was still a major concern for players despite reported comments from ICC chief executive Haroon Lorgat that security was a "non-issue."
"I have spoken to Haroon, so as to gain an understanding of the context of his comments, and remain confident that the ICC shares FICA's concerns regarding the importance of security measures at the World Cup," said May.
The World Cup in India has so far avoided much of the anxious discussion that surrounded the hosting of the Delhi Commonwealth Games in October, which saw leading countries question India's suitability as a location.
India has a host of home-grown militant groups from Maoists to separatists and is also targeted by Islamists from neighbouring Pakistan who reject New Delhi's presence in the disputed region of Kashmir.
Islamist gunmen in November 2008 laid siege to Mumbai, India's financial capital, leaving 166 people dead in attacks on two luxury hotels, a rail station and a Jewish centre.
"Security concerns will always be there but how you plan to face it is the issue," said security specialist Medha Chaturvedi of the Delhi-based Institute of Peace and Conflict Studies think-tank.
The United States on Thursday urged its citizens to be vigilant about terror risks if they are in the three host countries of India, Bangladesh and Sri Lanka during the World Cup.
Bangladesh has a history of political violence, but far less militancy than India, while Sri Lanka is now at peace for the first time in decades after the end of its ethnic war.
India's celebrated police officer K.P.S. Gill, who crushed a Sikh rebellion in Punjab state in the 1990s, said his country was ready for the task.
"India proved it during the Commonwealth Games that it can handle mega-events and in my opinion Bangladesh has handled the issue of terrorism in a much better fashion than Pakistan," Gill told AFP.
International experts say that the handling of security was essential, pointing out that there is no shortage of manpower.
"The implementation of a security plan is the most critical aspect," Jake Stratton of London-based Control Risks security consultancy firm told AFP.
"Some of the venues have been planning it for years and so they had plenty of time to put the necessary security into place and train the security staff," he added on the eve of the six-week tournament.
Sri Lanka, where government troops last year defeated ethnic Tamil Tiger rebels, ending the island's 37-year-old separatist war, said it was ready with its plan for the tournament.
"We are giving maximum security and we want to have an incident-free tournament," said Sri Lankan police chief Mahinda Balasuriya.
Resource:economictimes.indiatimes.com
Around 20,000 members of Bangladesh's elite paramilitary force the Rapid Action Battalion and regular officers have been deployed in Dhaka for the first match, police spokesman M. Sohail told AFP.
"All cricket venues, airports, the nine official hotels and transport for all the teams and officials fall under our security blanket," Sohail said as India and Bangladesh prepared to open the event.
Memories are still fresh of the attack in Lahore in March 2009 when gunmen ambushed the team bus carrying Sri Lanka's Test squad in the Pakistani city of Lahore.
Eight people were killed and seven Sri Lankan players and their assistant coach injured.
The attack led to Pakistan's removal by the International Cricket Council (ICC) as a co-host of the World Cup.
The Federation of International Cricketers' Associations (FICA) in a statement on Friday said its security consultants -- Eastern Star International (ESI) -- had "found proposed security arrangements to be sound."
"ESI informed they were confident that provided the plans are implemented in a professional manner the risk to the players in this event will be minimised as far as possible," the Australia-based association added.
It said that security was "a massive challenge" with 14 teams moving around the co-hosts Bangladesh, Sri Lanka and India, South Asia's biggest country, which has a long history of militant violence.
Tim May, the FICA chief executive, said security was still a major concern for players despite reported comments from ICC chief executive Haroon Lorgat that security was a "non-issue."
"I have spoken to Haroon, so as to gain an understanding of the context of his comments, and remain confident that the ICC shares FICA's concerns regarding the importance of security measures at the World Cup," said May.
The World Cup in India has so far avoided much of the anxious discussion that surrounded the hosting of the Delhi Commonwealth Games in October, which saw leading countries question India's suitability as a location.
India has a host of home-grown militant groups from Maoists to separatists and is also targeted by Islamists from neighbouring Pakistan who reject New Delhi's presence in the disputed region of Kashmir.
Islamist gunmen in November 2008 laid siege to Mumbai, India's financial capital, leaving 166 people dead in attacks on two luxury hotels, a rail station and a Jewish centre.
"Security concerns will always be there but how you plan to face it is the issue," said security specialist Medha Chaturvedi of the Delhi-based Institute of Peace and Conflict Studies think-tank.
The United States on Thursday urged its citizens to be vigilant about terror risks if they are in the three host countries of India, Bangladesh and Sri Lanka during the World Cup.
Bangladesh has a history of political violence, but far less militancy than India, while Sri Lanka is now at peace for the first time in decades after the end of its ethnic war.
India's celebrated police officer K.P.S. Gill, who crushed a Sikh rebellion in Punjab state in the 1990s, said his country was ready for the task.
"India proved it during the Commonwealth Games that it can handle mega-events and in my opinion Bangladesh has handled the issue of terrorism in a much better fashion than Pakistan," Gill told AFP.
International experts say that the handling of security was essential, pointing out that there is no shortage of manpower.
"The implementation of a security plan is the most critical aspect," Jake Stratton of London-based Control Risks security consultancy firm told AFP.
"Some of the venues have been planning it for years and so they had plenty of time to put the necessary security into place and train the security staff," he added on the eve of the six-week tournament.
Sri Lanka, where government troops last year defeated ethnic Tamil Tiger rebels, ending the island's 37-year-old separatist war, said it was ready with its plan for the tournament.
"We are giving maximum security and we want to have an incident-free tournament," said Sri Lankan police chief Mahinda Balasuriya.
Resource:economictimes.indiatimes.com
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