Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Source: FDA Drug Recalls
Tue Dec 4, 2018 5:07PM

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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:

NDCName and StrengthSizeLot NoExpiry
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mgBottles of 3030640841/2019
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mgBottles of 3030696295/2019
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 3030731488/2019
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 3030731498/2019
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30307609310/2019
0378-1721-93Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30307777211/2019
0378-1722-93Amlodipine and Valsartan Tablets, USP 10/160 mg  Bottles of 3030640851/2019
0378-1722-93Amlodipine and Valsartan Tablets, USP 10/160 mgBottles of 3030660633/2019
0378-1722-93Amlodipine and Valsartan Tablets, USP 10/160 mgBottles of 3030696385/2019
0378-1722-93Amlodipine and Valsartan Tablets, USP 10/160 mgBottles of 3030696396/2019 
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030640861/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030660613/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030660623/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030731459/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030731469/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030731479/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 30307609111/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 30307761911/2019
0378-1723-93Amlodipine and Valsartan Tablets, USP 5/320 mgBottles of 3030824323/2020 
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030660643/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030696456/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030696466/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030731429/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030731439/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 3030731449/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP 10/320 mgBottles of 30307761711/2019
NDCName and StrengthSizeLot NoExpiry
0378-5807-93Valsartan Tablets, USP 40 mgBottles of 3030637801/2019
0378-5807-93Valsartan Tablets, USP 40 mgBottles of 30307487910/2019
0378-5807-93Valsartan Tablets, USP 40 mgBottles of 3030866846/2020
0378-5807-93Valsartan Tablets, USP 40 mgBottles of 3030866876/2020
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 9030654452/2019
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 90307488010/2019
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 90307488310/2019
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 9030866886/2020
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 9030866896/2020
0378-5813-77Valsartan Tablets, USP 80 mgBottles of 9030867106/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030690195/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030690205/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030690215/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030690225/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030713547/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030713557/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030713577/2019
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030790231/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030790271/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030790281/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030790291/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030799962/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030799972/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030799982/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030836354/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030867156/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030867167/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030867177/2020
0378-5814-77Valsartan Tablets, USP 160 mgBottles of 9030886238/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030637831/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030637841/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030637851/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030640921/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030640931/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030640941/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703496/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703506/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703516/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703526/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703536/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030703546/2019
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030790301/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030790311/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030790321/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030790331/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030800112/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030802242/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030814983/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030815003/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030871267/2020
0378-5815-77Valsartan Tablets, USP 320 mgBottles of 9030884768/2020
NDCName and StrengthSizeLot NoExpiry
0378-6321-77Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mgBottles of 9030843632/2019
0378-6321-77Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mgBottles of 9030843642/2019
0378-6321-77Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mgBottles of 90309380012/2019
0378-6321-05Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mgBottles of 50030843632/2019
0378-6321-05Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mgBottles of 500309380012/2019
0378-6322-77Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 9020088808/2020
0378-6322-77Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 9030843582/2019
0378-6322-77Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 9030843592/2019
0378-6322-77Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 90309380112/2019
0378-6322-05Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 50030843592/2019
0378-6322-05Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 50030843612/2019
0378-6322-05Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mgBottles of 500309380112/2019
0378-6323-77Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mgBottles of 9030848872/2019
0378-6323-77Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mgBottles of 90309380212/2019
0378-6323-05Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mgBottles of 50030848872/2019
0378-6323-05Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mgBottles of 50030848882/2019
0378-6323-05Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mgBottles of 500309380212/2019
0378-6324-77Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mgBottles of 9030848892/2019
0378-6324-77Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mgBottles of 90309380312/2019
0378-6324-05Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mgBottles of 50030848902/2019
0378-6324-05Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mgBottles of 500309380312/2019
0378-6325-77Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 9030848602/2019
0378-6325-77Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 9030848612/2019
0378-6325-77Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 9030848622/2019
0378-6325-77Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 90309380412/2019
0378-6325-05Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 50030848622/2019
0378-6325-05Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mgBottles of 50030848632/2019

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.

Initial Press Release

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Original Article


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