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Mylan Initiates Nationwide Recall of 15 Lots of Valsartan Tablets

By Mike Botta | November 21, 2018

Mylan Pharmaceuticals is conducting a voluntary nationwide recall of select lots of Valsartan-containing products due to 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 recall includes six lots of Amlodipine and Valsartan Tablets, USP, seven lots of Valsartan Tablets, USP, and two lots of Valsartan and Hydrochlorothiazide Tablets, USP.

Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction.

The batches, listed below, were distributed in the U.S. between March 2017 and November 2018.

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

Earlier Tuesday, Mylan commented on a Nov. 9 Warning Letter issued by the Food and Drug Administration (FDA) relating to its Morgantown, WV manufacturing facility resulting from previously disclosed observations of the plant made by FDA in April 2018.

At the time, the FDA cited inadequate cleaning procedures at Morgantown along with drugs produced that did not meet specifications. As part of ongoing remediation activities, the company has discontinued a number of products from the site and is transferring some products to other sites.

The Morgantown facility continues to supply products for the U.S. market, but Mylan does not expect to have any significant new product launches from the site in 2019.

(Source: Mylan N.V.)

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