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.)
