Nationwide Recall of Pharmaceuticals

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient

For Immediate Release
November 20, 2018

Contact
Consumers
888-406-9305

Announcement
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA 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 according to the International Agency for Research on Cancer (IARC).

The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the U.S. between March 2017 and November 2018. The recalled batches are as follows:

NDC Product Description Strength Size Lot Number Expiry
0378-1721-93 Amlodipine and Valsartan Tablets, USP 5mg/160mg Bottles of 30 3066051 3/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10mg/160mg Bottles of 30 3079500 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3061986 11/2018
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079709 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3077618 11/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079708 1/2020
0378-5813-77 Valsartan Tablets, USP 80mg Bottles of 90 3063782 1/2019
0378-5814-77 Valsartan Tablets, USP 160mg Bottles of 90 3071352 7/2019
0378-5807-93 Valsartan Tablets, USP 40mg Bottles of 30 3061169 11/2018
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3081499 3/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080009 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080010 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3079205 1/2020
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3084886 2/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3093804 12/2019
Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan 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.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

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 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.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.

Life: Make Lemons or just Cry?

     Life some days can catch you with your pants down. This past summer I learned I had a small heart attack and also R-sided Congested Heart Failure. Wow, after all my other diagnosis' this is the one that really made me feel depressed and cry a lot. I did a lot of research on it and realized I was NOT in stage 1 since that was practically nothing. I was in probably midway thru stage 2 at that time. By now, seven months later, I feel I am beginning stage 3 or even 3 1/2. I know the saying when life throws lemons at you - you make lemonade. Also that God will never let you go thru anything that he doesn't think you can endure with him beside you. 

     I cry every day though. Is this my last? I made a bucket list of only 3 things when I was diagnosed with the CHF. I was lucky that I didn't have any arteries clogged - so I rejoice for that. But I do have high blood pressure and have to limit my salt, funny thing is since I was 15 and cooked at the Senior Center in CA, I never have salted anything since when I cook since.  BP is under control as is the high cholesterol which I never had before coming to Oklahoma. I've endured over 16 years with Meniere's. I have had Chronic Migraines since age 25. Some of you know that about me. Well, back to the bucket list. Listing of only 3 things:

1) to hold my son's first son when he had one - he had one Feb. 17th 2017 so I have gotten to do that - praise God.  

2) To see my first born Grand-daughter graduate. She is going to be Valedictorian and already has a scholarship to the school she wants to go to. She is 19 and graduates High School with Honors and gives her Valedictorian speech and already has her scholarship. I have been planning and saving for this coming June 3rd to see that happen. The bus ride is going to be 24 hours and 5 minutes with 4 different stops and changes. This will be hard on my Meniere's I know. I have my pug, Boo, registered as an ESA and can take her with me to keep me calm. Also, my fall on 2/21 getting out of the tub and doing the splits hurt my back in really horrible shape therefore I am in so much pain. But if I don't go my Daughter will be angry at me and disown me like she is the rest of the family). At the moment I am the only one going. So I will need to go and it is something I want to do as it is number 2 on my list.

3) To be recognized for my writings. I have had some writings put into those almanacs but you must pay so you really aren't getting there on your own merit. I have had some poems put in magazines but have only been paid in issues, And I have written for a column for an online magazine which made me feel pretty good but they went under. Recently, I wrote a short story for a contest-the winner gets $350---now that would make my bus ticket to a plane ticket and make my struggles in writing mean something to me. Not sure if I really will ever get number three accomplished before the end. 

     I feel like all I am doing is pasting a smile on my face no matter what the pain is from, my Fibromyalgia, back, migraines etc. or even dizziness from my Menieres. People ask why can't you just go" you look fine to me" and I just tell them I'm tired  or I have a migraine because I live with horrible fatigue too. Those are the only two excuses they understand--they don't believe in Fibromyalgia or some of the other things that are associated with it. I feel trapped in a body with no release, Sleep??? LOL. I do have to try to get a nap during the day. A shower feels like pellets hitting your skin it makes you not want to take one. I try very hard to take at least 2-3 per wk. The frustration of those who are non-believers makes my anxiety pop it's ugly head up and look around and say "you don't know whatcha' talking about". My Uncle can;t walk past me without poking me. He is a non-believer. 

I will be posting articles written about others to let you know what we go through. This is just my personal account of what my days are like.