Press Releases

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

HERTFORDSHIRE, England and PITTSBURGH, Dec. 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).  

Out of an abundance of caution, 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 expanded recalled batches are as follows:

NDC

Name and Strength

Size

Lot No

Expiry

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3064084

1/2019

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3069629

5/2019

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3073148

8/2019

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3073149

8/2019

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3076093

10/2019

0378-1721-93

Amlodipine and Valsartan Tablets, USP  5/160 mg

Bottles of 30

3077772

11/2019

0378-1722-93

Amlodipine and Valsartan Tablets, USP 10/160 mg

Bottles of 30

3064085

1/2019

0378-1722-93

Amlodipine and Valsartan Tablets, USP 10/160 mg

Bottles of 30

3066063

3/2019

0378-1722-93

Amlodipine and Valsartan Tablets, USP 10/160 mg

Bottles of 30

3069638

5/2019

0378-1722-93

Amlodipine and Valsartan Tablets, USP 10/160 mg

Bottles of 30

3069639

6/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3064086

1/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3066061

3/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3066062

3/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3073145

9/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3073146

9/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3073147

9/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3076091

11/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3077619

11/2019

0378-1723-93

Amlodipine and Valsartan Tablets, USP 5/320 mg

Bottles of 30

3082432

3/2020

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3066064

3/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3069645

6/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3069646

6/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3073142

9/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3073143

9/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3073144

9/2019

0378-1724-93

Amlodipine and Valsartan Tablets, USP 10/320 mg

Bottles of 30

3077617

11/2019






NDC

Name and Strength

Size

Lot No

Expiry

0378-5807-93

Valsartan Tablets, USP 40 mg

Bottles of 30

3063780

1/2019

0378-5807-93

Valsartan Tablets, USP 40 mg

Bottles of 30

3074879

10/2019

0378-5807-93

Valsartan Tablets, USP 40 mg

Bottles of 30

3086684

6/2020

0378-5807-93

Valsartan Tablets, USP 40 mg

Bottles of 30

3086687

6/2020

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3065445

2/2019

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3074880

10/2019

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3074883

10/2019

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3086688

6/2020

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3086689

6/2020

0378-5813-77

Valsartan Tablets, USP 80 mg

Bottles of 90

3086710

6/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3069019

5/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3069020

5/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3069021

5/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3069022

5/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3071354

7/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3071355

7/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3071357

7/2019

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079023

1/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079027

1/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079028

1/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079029

1/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079996

2/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079997

2/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3079998

2/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3083635

4/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3086715

6/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3086716

7/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3086717

7/2020

0378-5814-77

Valsartan Tablets, USP 160 mg

Bottles of 90

3088623

8/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3063783

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3063784

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3063785

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3064092

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3064093

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3064094

1/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070349

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070350

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070351

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070352

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070353

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3070354

6/2019

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3079030

1/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3079031

1/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3079032

1/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3079033

1/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3080011

2/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3080224

2/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3081498

3/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3081500

3/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3087126

7/2020

0378-5815-77

Valsartan Tablets, USP 320 mg

Bottles of 90

3088476

8/2020






NDC

Name and Strength

Size

Lot No

Expiry

0378-6321-77

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg

Bottles of 90

3084363

2/2019

0378-6321-77

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg

Bottles of 90

3084364

2/2019

0378-6321-77

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg

Bottles of 90

3093800

12/2019

0378-6321-05

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg

Bottles of 500

3084363

2/2019

0378-6321-05

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg

Bottles of 500

3093800

12/2019

0378-6322-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 90

2008880

8/2020

0378-6322-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 90

3084358

2/2019

0378-6322-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 90

3084359

2/2019

0378-6322-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 90

3093801

12/2019

0378-6322-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 500

3084359

2/2019

0378-6322-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 500

3084361

2/2019

0378-6322-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg

Bottles of 500

3093801

12/2019

0378-6323-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg

Bottles of 90

3084887

2/2019

0378-6323-77

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg

Bottles of 90

3093802

12/2019

0378-6323-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg

Bottles of 500

3084887

2/2019

0378-6323-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg

Bottles of 500

3084888

2/2019

0378-6323-05

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg

Bottles of 500

3093802

12/2019

0378-6324-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg

Bottles of 90

3084889

2/2019

0378-6324-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg

Bottles of 90

3093803

12/2019

0378-6324-05

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg

Bottles of 500

3084890

2/2019

0378-6324-05

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg

Bottles of 500

3093803

12/2019

0378-6325-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 90

3084860

2/2019

0378-6325-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 90

3084861

2/2019

0378-6325-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 90

3084862

2/2019

0378-6325-77

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 90

3093804

12/2019

0378-6325-05

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 500

3084862

2/2019

0378-6325-05

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg

Bottles of 500

3084863

2/2019

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. We routinely post information that may be important to investors on our website at investor.mylan.com.

Product Photos

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SOURCE Mylan N.V.

For further information: Christine Waller (Media), 724.514.1968, or Melissa Trombetta (Investors), 724.514.1813