Nationwide Recall of Blood Pressure Medication

This hits close to home as I must contact my pharmacy to see which lot was used to fill my Amlodipine and Valsarten for my own CHF and high blood pressure.

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

For Immediate Release
December 31, 2018

Announcement
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.


NDC Name and strength Count Lot number Expiry
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17013-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17014-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18001-A 12/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18002-A 12/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17008-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17010-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18002-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18003-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18007-A 03/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18008-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17008-A 05/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17014-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17015-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17016-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17017-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18002-A 01/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18004-A 01/2020
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17012-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17013-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17014-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17015-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17016-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17017-A 11/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17009-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18005-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18001-A 01/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17033-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17034-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17035-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17036-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17033-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17034-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17035-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17036-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17040-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17041-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17042-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17043-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17049-A 08/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17054-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17055-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17056-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17057-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17058-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17059-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17060-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17062-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17066-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17067-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17068-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17069-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18001-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18002-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18003-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18004-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18005-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18006-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18007-A 12/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17011-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17012-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17023-A 08/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17036-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17037-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17038-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17039-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17040-B 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18002-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18003-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18004-A 12/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17039-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17063-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17064-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17065-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP & 320/25mg 90 HTSB18029-A 03/2021
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17008-A 07/2019
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17009-A 09/2019
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Contact
Consumers
Aurobindo Pharma USA
pvg@aurobindousa.com
1-866-850-2876 Option 2
Consumers
Inmar\CLS-Medturn
rxrecalls@inmar.com
1-877-208-2407

My Recent Brush With Cancer

Two weeks ago my Doctor's Medical Assistant called me. She told me that the Mammogram I had in Dec. showed something and that I needed to see a surgeon for a biopsy. She gave me the Surgeon's name and phone number so I could schedule an appointment. I asked her which breast it was and she said she didn't have that information in front of her. I was a bit annoyed about that since I had worked for 30 years in the Medical Profession, part of it also being in Doctor's offices and Clinics before I moved on to Hospitals and Surgical Centers. We never gave information like she gave me over the phone for one. We always made an appointment for the patient to come in for a follow-up to have the doctor tell the patient. Also, why was it all of a sudden urgent when it has been 3 1/2 months since my Mammogram? Why did I not get a call sooner? Was it forgotten in the two appointments that I had seen my doctor in between on since the Mammogram? It seemed so wrong the way it was handled. And yet she DID NOT even have the RESULTS WITH HER when she called me!! I NEVER called a patient without the results right in front of me in all my 30 years of being in the Medical Field!
I made the appointment and my husband went with me to see the surgeon who was a very intelligent man. I was sent to another hospital for a different type of biopsy, than the more invasive surgical one the surgeon performed, due to the minuscule size. They were so tiny,actually 1/10th the size of buckshot. We had to view them with a magnifying glass. We had to drive to St. George, 45 minutes away, the biopsy was performed with a long needle and four little pieces were retrieved and a tiny titanium tag placed where they were removed. The tag was for future reference for either the surgeon if more surgery is required or future mammograms. Either way it is permanent & will not set off metal detectors at the Airports I'm told.
I waited four days for the results. Yesterday, I received the results that "I do not have Cancer". I am grateful since Breast Cancer took one of my Aunts when she was 54 and I am currently 51.
I am glad I have been having my Mammograms since the age of 40 years old. I had two fatty adipose masses taken out 7 years ago. Back then they were not detected when they were so small. They also watched them over a three year period. The first year the did a needle biopsy by withdrawing fluid only. Year two was no growth or anything. Year three they had tripled in size so they did a ultrasound and decided to remove them. They were benign also. We had expected them to be 99% benign before they were removed though.
Therefore, I am a great advocate about getting your Mammogram every year. It is very important. DO NOT PUT IT OFF. Early Detection is the best way for Early Treatment. The new Mammogram technology is great especially how they could detect such a small tiny tumor as they did on my mammogram this year versus 7 years ago was totally amazing to me. It sure proved to me that if it had gone the other way I would have had very early detection and a very very good chance of Treatment and Recovery.

Smoking In Public Places:

How It Can Affect Everyone...

In November 2003, the Center for Disease Control (CDC), reported that "using data from national health surveys, the researchers calculated that 8.6 million people in the United States have a serious illness caused by smoking."That's a little bit more than the entire population of New York City." Think of that number for just a moment nearly nine million people, millions, yes that's what I said, millions of people have an illness somehow related/caused by smoking. Wow, staggering huh? You bet. That got my attention.

The CDC went on to say "for smoking, it's incredibly important to meet the 2010 goals because smoking is the leading cause of (preventable) death in this country, and if we can reduce smoking prevalence we can save a lot of lives, said Corinne Husten, MD, a medical officer with the CDC's Office on Smoking and Health. Reducing the smoking rate would also cut the staggering number of Americans living with debilitating diseases caused by tobacco." It didn't say if this included people with illness from second-hand smoke.

Facts from the American Lung Association say that "secondhand smoke, also known as environmental tobacco smoke (ETS), is a mixture of the smoke given off by the burning end of a cigarette, pipe or cigar and the smoke exhaled from the lungs of smokers. It is involuntarily inhaled by nonsmokers, lingers in the air hours after cigarettes have been extinguished and can cause or exacerbate a wide range of adverse health effects, including cancer, respiratory infections, and asthma.

Secondhand smoke has been classified by the Environmental Protection Agency (EPA) as a known cause of cancer in humans (Group A carcinogen).
Secondhand smoke exposure causes disease and premature death in children and adults who do not smoke. Secondhand smoke contains hundreds of chemicals known to be toxic or carcinogenic, including formaldehyde, benzene, vinyl chloride, arsenic ammonia and hydrogen cyanide.

Secondhand smoke causes approximately 3,400 lung cancer deaths and 46,000 heart disease deaths in adult nonsmokers in the United States each year.

Nonsmokers exposed to secondhand smoke at work are at increased risk for adverse health effects. Levels of ETS in restaurants and bars were found to be 2 to 5 times higher than in residences with smokers and 2 to 6 times higher than in office workplaces." (italics mine)

It's when we go to these restaurants, bars or to our own places of work that allow smoking inside we become exposed. I say ban smoking from inside the premises entirely. In Utah, when I lived there, ten years ago, they began to ban smoking in restaurants. The only places that could allow smoking had to become clubs, even diners/restaurants and had to display a sign on the entrance "this is a smoking establishment". This I think is a great alternative for smokers. If select restaurants actually have a ninety percentile clientele of smokers it may be worth the establishments effort/cost to do something like that, if the state allows it as an alternative. I now live in Idaho. Here the bars, a few restaurant and most of the bowling alleys have an area/patio established outside where people can step out and have a smoke. Another great alternative as long as the person stays in the air long enough to air out. Or spray off with some cinnamon air freshener. Recently the hospital here went to a non-smoking establishment, offering it's smoking employees free classes to kick the habit. You can't smoke anywhere inside nor outside on the entire campus either.

I've worked in the healthcare field for many years, and have seen many illnesses related to cigarette smoking. According the the American Lung Association "secondhand smoke is responsible for between 150,000 and 300,000 lower respiratory tract infections in infants and children under 18 months of age, resulting in between 7,500 and 15,000 hospitalizations each year, and causes 430 sudden infant death syndrome (SIDS) deaths in the United States annually.
Secondhand smoke exposure may cause buildup of fluid in the middle ear, resulting in 790,000 physician office visits per year.10 Secondhand smoke can also aggravate symptoms in 400,000 to 1,000,000 children with asthma."

The CDC went on to further report that "most of those people - about 59% - have either chronic bronchitis or emphysema, lung conditions that make breathing difficult and can be deadly. Smoking-related cancers accounted for 13% of the serious diseases; more than 1.5 million people are affected.

Among cancer cases, lung cancer accounted for only 1% of cases (184,000 people). Yet lung cancer strikes nearly 172,000 Americans each year, and kills more people than any other cancer. Why weren't the numbers in the survey higher?
Hyland has one explanation. "The reality is, if you have lung cancer, the survival is just a few months."
Lung cancer is frequently not found until it is advanced, when it kills quickly. Many patients simply don't survive long enough to be found by surveys like the ones used to collect this data.

This is the first time researchers have tried to quantify the chronic health effects of smoking, as opposed to looking at the number of deaths it causes. But as shocking as the figure is - 8.6 million Americans with serious illnesses - Hyland says it probably understates the problem.
"Our estimates, I think, are very conservative," he said.

The surveys only looked at a handful of serious smoking-related illnesses, he explained, and did not include less debilitating conditions, like sinusitis, impotence or impaired wound healing. Also, only diseases related to smoking were included; if the researchers had also included diseases related to other tobacco products, like chewing tobacco or snuff, the numbers would have been higher, Hyland said."

I'm a non-smoker, I've got grown kids who are smokers and have always had them go outside, even in the winter to smoke. Cigarette smoke gives me migraines. Smokers do have rights too I realize that, however, they must realize what it is doing to themselves and other people around them also. The statistics above should at least make you stop and think about smoking to some degree. Whether it be that you should quit for the sake of your own health or at least think of those around you when you do light up.

www.cancer.org(re:CDC report)
www.lungusa.org (re:Second Hand Smoke facts)

All Comments Encouraged And Welcomed.