Holistic Nutrition ~ Guidelines For Healthy Eating

Holistic Nutrition ~ Guidelines For Healthy Eating

What To Eat

1. Drink adequate amounts of purified water - at least eight 8-ounce glasses daily. Even mild dehydration will interfere with the digestive process and aggravate several symptoms and diseases.


2. Choose organic food as much as possible to avoid pesticides, herbicides, genetically modified (GMO) foods, and irradiated food. Fresh organically grown food has more nutrient value and tastes better, and organic meats and dairy don't contain hormones and antibiotics.


3. Select whole grains when buying foods such as bread, pasta, rice, tortillas, and cereal. Whole grains provide more nutrients and fiber.About 22 natural nutrients are processed out of grains in the making of refined flour products. 'Enriched' is a misnomer since only 6 or 8 synthetic nutrients are actually returned after processing.

4. Try to buy locally grown fresh fruits and vegetables. Sometimes it's better to eat freshly harvested local produce that isn't certified organic, rather than organic produce that was harvested before ripening and transported thousands of miles to the grocery store.If you can't grow your own produce, find a Farmers' Market in your area, or ask your grocer to offer local produce.
5. Essential fatty acids are necessary for good health, so eat plenty of good fats. The low-fat craze was based on faulty research and caused a decline in health over decades. Use organic cold-pressed oil such as extra virgin olive oil for salads. Cooking requires an oil that can be heated without being denatured, such as coconut oil. Flax seed oil is a great addition to a breakfast smoothie.


6. Eat raw and minimally processed whole living food as much as possible. Foods in their natural state contain more nutrients and active enzymes.


7. Eat a variety of nutrient-rich healthy foods. There is no single food that provides the more than 40 different nutrients we need for good health. Experiment with different foods and recipes.

What To Avoid

• Eliminate refined sugar, high fructose corn syrup, and artificial sweeteners such as aspartame (NutraSweet, Equal) and sucralose (Splenda). All contribute significantly to serious health problems.


• Salt: Limit sodium to less than 2,300 mg per day - equivalent to about one teaspoon of salt. Check food labels; you'll be amazed how much sodium is added to processed foods. Substitute regular table salt for something healthier, like sea salt or Himalayan salt.


• Coffee and sodas - non-foods that have many destructive physiological consequences which cause several illnesses and chronic disease.


• Trans fats (hydrogenated vegetable oils)


• Don't microwave food or beverages. Use a toaster oven, double boiler, tea kettle, or other appliance to heat or cook food.


• Food additives: artificial colors and flavors, preservatives, MSG


• Genetically modified (GMO) foods: Unfortunately, it's not required that the consumer be notified about the presence of GMO foods. Most canola and soy is GMO, so never buy non-organic canola oil or non-organic soy products like soy milk, tofu, or soy protein powder.

Other Considerations of Holistic Nutrition

• Use natural plant-based digestive enzymes to enhance your digestion. Enzymes will also reduce the formation of certain digestive by-products that can lead to intestinal toxicity and autointoxication. Our ability to produce enzymes decreases as we get older, and cooking and processing destroys the enzymes that were originally part of the food.


• Use a high quality daily multi-nutrient to supplement your healthy food choices. Even most organic produce doesn't have the same nutritional value that foods had several decades ago.Modern agricultural and food distribution practices and compromised soil, air, and water quality have degraded the nutritional content of food. Today we would have to eat much larger portions to get sufficient nutrients from our food.
• If changing to a healthier eating lifestyle is a major shift for you, make gradual changes. Developing new eating habits can feel overwhelming and confusing, and that may interfere with your success in making permanent changes.You can start with substitution. For instance, if you love hamburgers, stop buying the fast food junk and make your own. Buy organic or free-range ground meat, or organic vegi-burger patties. Use whole grain buns, and organic lettuce, cucumber and tomato. Try different condiments - like pesto thinned with olive oil instead of using mayonnaise.
• Clean out your kitchen pantry and refrigerator to get rid of unhealthy foods. Read the label ingredients to help decide what to toss or give away.


• Eat moderate portions; remember that a serving of meat is 3 ounces - about the size of a deck of cards. A serving of pasta is about a half cup. We've become used to super-sized portions, but we're turning into a nation of sick super-sized people.


• Start out the day with a nutritious breakfast. A smoothie with almond milk, fruit, coconut or flaxseed oil, protein powder and fiber is delicious and will jump start your metabolism and provide a lasting energy boost. Try to confine your eating window to 6 to 8 hours, which enables a fasting period of 16 to 18 hours. This allows your body a better chance to clean out cell debris and regenerate without having to expend more energy on digestion.


• Treat yourself! A healthy diet doesn't have to deprive you of the foods you love. Experiment with healthy substitutes and use moderation.

The sickening truth about disinfecting wipes: They are made from toxic ingredients that can cause cancer

Jun 8, 2020 | Cancer | 0 comments

If you use disinfecting wipes, it’s likely because you want to rid your home of germs. They might do a good job of accomplishing that task, but you could be introducing something that is potentially even more harmful when you use them.

In fact, the EPA regulates disinfecting wipes as pesticides, which actually makes sense when you consider that they are meant for controlling germs, which are a type of pest. That’s also why you’ll find instructions on using the product for killing pests on the label, as well as first aid directions for accidental exposure.

Just what is in these pesticide wipes that you’re spreading all over your kitchen and other important surfaces on the pretense of “good health”?

Most of them contain toxic quaternary ammonium compounds. Also known as “quats,” these compounds can cause allergies and asthma, and they can irritate your lungs, eyes and skin. If you see terms like “Alkyl C12-18,” “Alkyl C12-14,” or “n-Alkyl dimethyl benzyl ammonium chloride” on the ingredients list, it’s time to start shopping for a replacement. Quats have also been linked to reproductive problems.

Some wipes contain cancer-causing ortho-phenylphenyl. Premoistened wipes contain chemicals like parabens and formaldehyde releasers to stop bacteria from growing within the package. If your wipes contain chlorine bleach, you should know that it’s been linked to asthma.

You need to use extra care around children, who are even more susceptible to pesticide dangers from disinfectant wipes. Their smaller size and developing organs make them highly vulnerable, so they should never use the wipes. Moreover, limited exposure to living bacteria can help to boost people’s immune systems. Excessive disinfectant use has been cited as a contributor to the rise of superbugs.

The power of the elements: Discover Colloidal Silver Mouthwash with quality, natural ingredients like Sangre de Drago sap, black walnut hulls, menthol crystals and more. Zero artificial sweeteners, colors or alcohol. Learn more at the Health Ranger Store and help support this news site.

Keeping your home clean without using dangerous chemicals

So what should you do if you’re worried about germs? Consider this: There isn’t any evidence that using disinfectants to clean is better at preventing illness than the standard soap-and-water approach. In fact, experts have called for offices and classrooms to stop using these wipes, advising that they’re only appropriate in certain situations, such as cleaning up bodily fluids from a person who has a contagious illness. In those cases, however, you’d be better off opting for disinfectants whose active ingredients are safer. Some good choices include lactic acid, citric acid, caprylic acid, or hydrogen peroxide.

Wet clothes or paper towels work surprisingly well, but if you want to give your cleaning efforts some extra strength, consider using some essential oils inside a spray bottle. Lemon, peppermint, tea tree, and thyme oil can all get the job done while adding a pleasant and safe fragrance at the same time.

In fact, giving up toxic wipes in favor of soap and water could actually leave your surfaces cleaner. That’s because, as the Environmental Working Group points out, most people don’t use these wipes properly in the first place. They generally need to remain on the surface you wish to disinfect for a period of time; the instructions will say how long a particular product needs to stay on the surface. Keeping a surface wet for four to ten minutes, as directed on many labels, can take up a lot more wipes than you might think.

After doing that, the surface needs to be rinsed with water. If you were disinfecting a cutting board or kitchen counter that might come into contact with food, it also needs to be washed again before using.

Thankfully, these toxic wipes aren’t really necessary for most situations, and you should have no trouble getting by with the tried-and-true method of cleaning with soap and water. You’ll save a lot of money, and best of all, you won’t be putting your family’s health in danger or contributing to the superbug problem.

Sources for this article include:

NaturalHealth365.com

OneGreenPlanet.org

NaturalNews.com

Originally posted: http://www.pollution.news/2018-06-19-disinfecting-wipes-made-from-toxic-ingredients-that-can-cause-cancer.html

Author: Isabelle Z.

Pain reliever products recalled

Sanvall Enterprises Recalls Rapid Alivio Pain Relieving Roll-On Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

Due to the extraordinary circumstances surrounding COVID-19, some of the remedies identified in recall press releases may not be available at this time. Consumers should check with recalling firms for further details.
It is important to remember that CPSC and recalling firms urge consumers not to use recalled products.

Name of product:

Sanvall Rapid Alivio Pain Relieving Roll-On

 

Hazard:

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Remedy:

Refund

 

Recall date:

May 27, 2020

 

Units:

5,400

 

Consumer Contact:

Sanvall Enterprises collect at 305-887-1090 from 9 a.m. to 5 p.m. ET Monday through Friday, email at SanarNaturals@Sanvall.com and in the body of the email provide your name, address, and photo of the product or online at www.Sanvall.com and click on "Recall - Important Safety Information - Rapid Alivio Roll-On" for more information.

Recall Details

Description:

This recall involves Sanvall Rapid Alivio Pain Relieving Roll-On in a 3 fl. oz (88.5 mL) white plastic bottle with a white cap and a red, white and blue label. "Rapid Alivio," "Maximum Strength Pain Relieving Liquid" and "Para Dolor Muscular" are printed on the label. Lot numbers 18032201, 18032301, 19040501, or 19052801 are printed on the bottom of the bottle. UPC code 605100014225 is printed on the side of the label.

 

Remedy:

Consumers should immediately store the pain relieving roll-on in a safe location out of reach of children and contact Sanvall Enterprises for a full refund.

Incidents/Injuries:

None reported

Sold At:

Navarro Discount Pharmacy and Walmart stores in South Florida from August 2016 through June 2019 for about $6.

Manufacturer(s):

Sanvall Enterprises Inc., of Doral, Fla.

Manufactured In:

United States

 

Recall number:

20-126

RECALL: Thyroid medication, due to super potency

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid (Thyroid Tablets, USP) Due to Super Potency

Company Announcement Date: May 22, 2020

FDA Publish Date: May 22, 2020

Product Type: Drugs

Reason for Announcement: Recall Reason Description, Super potency

Company Name: Acella Pharmaceuticals, LLC

Brand Name: Acella

Product Description: 30-mg, 60-mg and 90-mg NP Thyroid

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Company AnnouncementAcella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall.
NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.
To best identify the product, the NDC's, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella's direct accounts.

Product	NDC	Lot #	Exp. Date
NP Thyroid 30 mg	42192-329-01	M329A19-1	20-Dec
		M329H18-1	20-Jul
		M329J18-1	20-Aug
		M329J18-2	20-Aug
		M329J18-3	20-Aug
		M329M18-2	20-Nov
NP Thyroid 60 mg	42192-330-01	M330J18-2A	20-Aug
		M330J18-3	20-Aug
NP Thyroid 90 mg	42192-331-01	M331G18-1	20-Jun
		M331J18-1	20-Aug
		M331J18-2	20-Aug
		M331M18-1	20-Nov
		M331M18-2	20-Nov

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. 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 Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• 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.

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Company Contact Information

Consumers:

Allen Fields, Senior Vice President, Clinical and Regulatory Affairs

1-800-541-4802

RECALL: Breast implants and/or tissue expanders

Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell Recall

Company Announcement Date: June 01, 2020

FDA Publish Date: June 01, 2020

Product Type: Medical Devices

Reason for Announcement: Increased risk of BIA-ALCL

Company Name: Allergan Aesthetics

Brand Name: BIOCELL

Product Description: Breast Implants

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Company Announcement

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL breast implant units.

It is important to note the United States Food and Drug Administration (FDA) has made the following recommendation, "If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider."¹

Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics' www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.

"Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL recall, and knows their implant type and implant history," said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics.

If patients are not aware of the BIOCELL recall previously announced on July 24, 2019 and do not know the type of implant that they have in place or their implant history, they should either:

• Go to www.BIOCELLinformation.com Disclaimerto reach out to Allergan Aesthetics to determine if the company has their implant information.
• Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.

Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. External Link DisclaimerThe website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have.

Patients with BIOCELL implants or tissue expanders or a history of BIOCELL implants or tissue expanders should go to www.BIOCELLinformation.com External Link Disclaimerto learn about the BIOCELL recall, symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the importance of breast self-examination and the need for regular breast implant monitoring.

"We are determined to make sure every woman has the information they need related to the BIOCELL voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking," said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics.

About the GLOBAL BIOCELL Recall

On July 24, 2019 Allergan initiated a voluntary global recall of its BIOCELL breast implants and tissue expanders. Allergan has continued a global basis to ensure that patients and health care professions are notified about the BIOCELL recall. The Company issued global press releases and distributed letters directly to healthcare professionals regarding the recall. To generate awareness and provide

a resource for patients, the Company launched a dedicated website, www.BI- OCELLinformation.com, to help patients identify their breast implants and to provide information and resources related to the risk of BIA-ALCL.

Allergan Aesthetics, an AbbVie company will continue to work closely with global regulatory authorities and societies and patient advocacy groups to provide important BIOCELL information to patients and health care professionals regarding the voluntary recall.

For more information on the BIOCELL recall, please click here for the press release.

More information on BIA-ALCL

BIA-ALCL is not breast cancer--it is a type of non-Hodgkin's lymphoma (cancer of the immune system). At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with
BIOCELL? textured breast implants. However, BIA-ALCL is a serious condition and
can lead to death, especially if not diagnosed early or treated promptly.

About Allergan Aesthetics

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.External Link Disclaimer

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. External Link DisclaimerFollow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

¹ FDA.gov; 9/12/2019: Allergan Voluntarily Recalls BIOCELL Textured Breast Im- plants and Tissue Expanders

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Company Contact Information

Consumers:

More information

www.BIOCELLinformation.com

Nationwide recall of popular medication because of cancer concerns

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

Company Announcement Date: May 29, 2020

FDA Publish Date: June 01, 2020

Product Type: Drugs

Reason for Announcement: Due to detection of N-Nitrosodimethylamine (NDMA)

Company Name: Amneal Pharmaceuticals LLC

Brand Name: Amneal

Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg

Company AnnouncementAmneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level.
Amneal was notified by the U.S. FDA that the Agency's testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.
To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
Amneal's Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.
Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.
Metformin HCl Extended Release Tablets, USP, 500 mg

53746-178-01	100 count bottles
53746-178-05	500 count bottles
53746-178-10	1000 count bottles
53746-178-90	90 count bottles
53746-178-Bulk	Bulk Box
65162-178-09	90 count bottles
65162-178-10	100 count bottles
65162-178-11	1000 count bottles
65162-178-50	500 count bottles

Metformin HCl Extended Release Tablets, USP, 750 mg

53746-179-01	100 count bottles
53746-179-Bulk	Bulk Box
65162-179-10	100 count bottles

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.
Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.
Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealProductRecallDS@amneal.com, Monday - Friday, 8:00 am - 5:00 pm, EST, for further information.
Pharmacies should cease dispensing product.  Amneal is notifying Retailers via mail (UPS Standard Overnight) who have been provided Amneal's Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which will include instructions for retailer and consumer product return.
For information concerning this recall please call Amneal at 1-833-582-0812 or email to AmnealProductRecallDS@amneal.com,  Monday - Friday, 8:00 am - 5:00 pm, EST.
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am - 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.
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
• 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.
Safe Harbor Statement
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as "may," "will," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "assume," "continue," and similar words are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the "Company"). Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.

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Company Contact Information

Consumers:

Amneal

1-833-582-0812

AmnealproductrecallDS@amneal.com

Diabetes medication recalled, probable human carcinogen warning

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Summary

Company Announcement Date: June 02, 2020

FDA Publish Date: June 05, 2020

Product Type: Drugs

Reason for Announcement: Due to detection of N-Nitrosodimethylamine (NDMA)

Company Name: Marksans Pharma Limited, India

Brand Name: Time-Cap Labs, Inc.

Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500mg

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Company Announcement

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events related to this recall to date.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with '101' on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg

Lot #: XP9004

Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot. Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

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 Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• 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 or call Time-Cap Labs, Inc. at 1-877-376-4271 or Fax at 631-753-2220

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

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Company Contact Information

Consumers:

Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.

631-753-9090, ext. 160

imcgregor@timecaplabs.com

Media:

Dr. Meena Rani, (US Regulatory Agent and Corporate Vice President, Regulatory Affairs & Compliance)

631-833-9341

usagent@marksanspharma.com

You Won't Believe What They Admitted on the News in 1971...