Summary

Company Announcement Date: December 04, 2018 FDA Publish Date: December 04, 2018 Product Type: Drugs

Prescription Drugs Reason for Announcement: Recall Reason Description Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Company Name: Mylan Pharmaceuticals Brand Name: Brand Name(s) Mylan Product Description: Product Description Valsartan-containing products

Company Announcement

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.

Company Contact Information Consumers: Stericycle 1-888-406-9305 Media: Christine Waller (724) 514-1968