MYLAN N.V.: Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP

Mylan N.V. issued the following announcement on Nov. 20.

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.

Original source can be found here.

Want to get notified whenever we write about Mylan N.V ?
Next time we write about Mylan N.V, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.
Organizations in this story

Mylan N.V Mylan Blvd Canonsburg, PA 15317