HERTFORDSHIRE, England and PITTSBURGH/PRNewswire/ -- 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.