Atrial fibrillation is a turbulent rhythm of the upper chambers of the heart called the atria. It is the most common heart rhythm disorder, affecting more than 2.7 million people in the United States.

Did you know that people who have close relationships at home, work, or in their community tend to be healthier and live longer? One reason, according to the National Heart, Lung, and Blood Institute (NHLBI), is that we're more successful at meeting our health goals when we join forces with others. NHLBI launched the #OurHearts movement to inspire us to protect and strengthen our hearts with the support of others. 

Every five years since 1980, a new edition of the Dietary Guidelines for Americans is published. Its goal is to make recommendations about the components of a healthy and nutritionally adequate diet to help promote health and prevent chronic diseases for current and future generations. Although many of its recommendations have remained relatively regular over time, the Dietary Guidelines have evolved as scientific knowledge has grown. These advancements have provided a greater understanding of, and focus on, the importance of healthy eating patterns, and how foods and beverages act synergistically to affect health. Therefore, healthy eating patterns are a focus of the 2015-2020 Dietary Guidelines.

Raise awareness about heart health and urge those around you to prevent heart disease. #OurHearts are healthier together. Join us!

Despite the type of diet you follow, to lose weight, you need to burn more calories than you take in each day. For most people, cutting about 500 calories per day is an excellent place to start. If you eat 500 calories less daily, you should lose about one pound per week.

Working long hours has been linked to up to 70% increased risk of masked hypertension and a 66% higher risk of sustained hypertension in a recent study in Quebec, Canada.

 The American Society of Echocardiography has announced a new set of guidelines for using stress echocardiography in patients with ischemic heart disease, replacing its 2007 recommendations.

     Recent research suggests obesity, high blood pressure, and diabetes could have a lot to do with Cardiovascular disease's (CVD) tendency to present later in life in women than in men.

On #LawEnforcementAppreciationDay, we at Memorial Katy Cardiology Associates would like to thank our community's finest and every law enforcement officer around the world for what you do. Thank you for service!

Self-care is more than just a millennial fad—it’s a lifestyle must-have for everybody. Its well-known benefits for mental health are unparalleled, running the gamut from stress relief to increased focus and productivity. Its physical benefits are just as impressive, too. In fact, self-care has been known not just to increase overall health, but also alleviate symptoms of diseases, including heart disease.

It’s National Nurse Practitioner Week, and Memorial Katy Cardiology Associates wants to recognize all nurse practitioners for their hard work and thank them for their dedication to patient care with a huge THANK YOU! Did you know that nurse practitioners offer 234,000 solutions to strengthening health care for America? Nurse practitioners are the health care providers of choice for millions of Americans each year, thanks to the high-quality, patient-centered primary, acute, and specialty care they provide. Nurse practitioners order, perform, and interpret diagnostic tests and can prescribe medication and other treatments.

Veterans Day, the federal holiday on November 11 of every year, affords Americans the opportunity to pay our respects to all who have served our country honorably during war and peacetime. 

Let's face it: dieting is hard, especially for people with busy lifestyles. Sometimes, we don't feel like going through all the trouble and would rather stick to our fast-food diets. However, when we factor in the dangers of an unhealthy diet (heart disease, obesity, diabetes, stroke, increased probability for certain cancers, asthma, osteoarthritis, etc.) and the many benefits of eating healthy (longer life, more energy, etc.) it becomes clear that the best time to start a diet plan is now.

If you’re a senior with a growing interest in yoga, keep in mind that yoga can help relieve many of the mental and physical problems common among older adults, such as stress, depression, and joint pain. It also offers many benefits for caregivers, which means yoga can be an enjoyable activity for you and your caregiver to do together. Don’t be scared off by images of people twisted into complex poses. Yoga is a holistic, soothing discipline that’s highly adaptable to diverse groups with different physical needs and capabilities. However, you should know what you’re getting into first and find the right instructor and form of yoga before getting started.

Smoking is a leading cause of preventable deaths and disease:

The leading cause of deaths and disease in the United States, as well as the whole world, is smoking. There is no doubt about in the harms and effects of smoking.

Not getting enough sleep may put some people at risk for much more than being drowsy the next day, a new study says.

When a company announces a recall, market withdrawal, or safety alert, MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.
Read Announcement

Summary

Company Announcement

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium / hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide 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 product/lots included in the expanded recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots

 

Losartan Potassium tablets, USP and Losartan Potassium / Hydrochlorothiazide tablets, USP were distributed nationwide to Torrent's wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited 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. Torrent is arranging for return of all recalled products to Qualanex. 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 Torrent Pharmaceuticals Limited at:

• 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
• Medinfo.Torrent@apcerls.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 should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm
Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Original Recall
Link to 1st Expansion Recall
Link to 2nd Expansion Recall
Link to 3rd Expansion Recall
Link to 4th Expansion Recall

Carly Simon may have been talking about a different kind of vanity. But, if you’re part of the 50 percent of adults living with a leg vein disorder, MKC Vein & Vascular Center is here with the best way to treat and prevent varicose and spider veins.

Nearly 70 percent of current adult smokers say they want to stop.

Memorial Day is the time to remember and honor those who risked their lives to protect us and the country. Reach out to your friends, family and loved ones with our Memorial Day wishes filled with pride, warmth and togetherness.

Routine visits to the doctor’s office typically involve a single blood pressure measurement. For people with borderline hypertension, or high blood pressure, additional checks at the office are often necessary, in conjunction with having more checks done at home. How many exactly?

Hypertension, otherwise known as high blood pressure, is widespread in the United States. It is approximated that one in every three adults in the United States suffers from high blood pressure, and for adults aged 65 or older, this number climbs to over 60 percent.

Summer is quickly approaching and with it comes grilling season, chances are at least once this summer you’ll wonder about the effects of that delicious, juicy grilled steak will have on your heart?

In 1993, the American Nurses Association declared a national week to celebrate and elevate the nursing profession. Each year, the celebration starts on May 6th and ends on May 12, Florence Nightingale's birthday. The purpose of this week-long celebration is to raise awareness of the value of nursing and help educate the public about the role nurses play in meeting the healthcare needs of Americans. 

When a company announces a recall, market withdrawal, or safety alert, MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.
Read Announcement

 

Summary

---

Company Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide 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. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

 

Losartan potassium tablets, USP and Losartan potassium/ hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited 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. Torrent is arranging for return of all recalled products to Qualanex. 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 Torrent Pharmaceuticals Limited at:

• 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

• Medinfo.Torrent@apcerls.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 should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

 

 

Worldwide headlines read: “Aspirin no longer useful for stroke and heart attack prevention”

Source of this buzz was the new guidelines issued from a joint American College of Cardiology and American Heart Association (ACC/AHA) guideline published in early March, 2019. The new guideline is meant solely for primary prevention. Anyone with known clinically significant atherosclerotic vascular disease (ASCVD) is excluded from this guideline as their care is categorized as “secondary prevention”. One may suppose that the only topic in the guideline was aspirin use for the primary prevention of heart attack and stroke. In fact, the recommendations involved other key topics that are summed up here in text and pictures. But first, let’s discuss aspirin.

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg NDC 68645-494-54

The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) which are listed below:

LEGACY NDC#	Name and Strength	Count	Legacy Lot #	Expiry
68645-494-54	Losartan Potassium Tablets USP 50 mg	30	180190	10/2020
68645-494-54	Losartan Potassium Tablets USP 50 mg	30	180191	10/2020
68645-494-54	Losartan Potassium Tablets USP 50 mg	30	181597	02/2021
68645-494-54	Losartan Potassium Tablets USP 50 mg	30	181598	02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Initial Press Release

Considering the risks of cardiovascular disease related to sedentary behaviors, the study conducted by Yang L, Cao C, Kantor ED, et al. illustrates concerning—though not surprising— data. Greater effort to reduce sedentary habits together with promotions of regular physical activity are essential to improving public health.

When a company announces a recall, market withdrawal, or safety alert, the MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.

Apple Heart Study

This research study assessed whether the Apple Heart Study App can effectively use data collected on the Apple Watch to detect irregular heart rhythms, along with those from potentially serious heart conditions such as atrial fibrillation. 419,093 people participated in the study.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Please call your local pharmacy to find out if your prescription is affected by this recall.

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg 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. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed 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.

Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date.

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide 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. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 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. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan 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 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.

Amlodipine Valsartan Tablets USP and Valsartan Tablets USP were distributed nationwide to AurobindoPharma USA, Inc. and Aceteris Health LLC wholesale, distributor, repackager and retail customers. AurobindoPharma 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. AurobindoPharma USA, Inc. is arranging for return of all recalled products to Inmar. 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 AurobindoPharma 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 aurobindorecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

 

 

 

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below:

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Stericycle is notifying Camber’s distributors and other customers by recall letter and arranging for return of recalled product of Losartan Potassium Tablets.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals’ Med Line at 1-866-495-1995 Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug administration.

 

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

Risk Statement: The impurity detected 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. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination 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.

The product subject to recall is 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 Manufacturer Product Description Lot/Batch Expiration Date
33342-0052-10 Macleods Pharmaceuticals Limited Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles BLM715A Jul -2019
The representation of the Label is as provided below

Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

If you have any general questions regarding the return of this product please contact Qualanex via email at recall@qualanex.com or call 888-280-2042 (7:00 am to 4:00 pm CST Monday to Friday).

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.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program by phone, on line, either by regular mail or by fax.

1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
   This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This just in, the Heart Disease and Stroke Statistics 2019 update from the American Heart Association reveals that:

Strokes do not discriminate by age.

They hit once the factors are right – and these factors may be found as often in younger adults who have strokes as in older populations, according to a new study.

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Please call your local pharmacy to find out if your prescription is affected by this recall.

February is for lovers. February also reminds us to take care of our heart; it is American Heart Month.

The annual celebration started in 1963 to encourage Americans to join the battle against heart disease. A presidential proclamation pays tribute every year to researchers, physicians, public health professionals and volunteers for their tireless efforts in preventing, treating and researching heart disease, which is the leading cause of death for both men and women within the U.S.

Hospitals and health systems around the country celebrate American Heart Month by consigning to raise awareness in their communities regarding heart disease. Employees wear red and volunteers knit or crochet pint-size red hats for newborns. They hold free screenings and heart health awareness events.

It’s an excellent time to commit to a healthy life style and make small changes that may result in a lifetime of heart health. If you’re not doing so already, become involved in American Heart Month. Get involved and spread the word about strategies for preventing heart disease and living heart healthy lives!