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Statement: Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure. To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan.

Patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.

Teva Pharmaceuticals USA is notifying its distributors and customers by certified mail and is arranging for return/reimbursement of returned recalled products. Distributors and retailers that have product that is being recalled should immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product.

Customers and patients with medical-related questions, information about an Adverse Event or other questions about the Teva products being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

Adverse reactions or other problems experienced with the use of the products may also be reported to Teva directly at 888-838-2872 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Patient safety and product quality is critical to Teva. As always, Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation. This issue is not limited to valsartan medicines manufactured and distributed by Teva. Some valsartan-containing products manufactured and distributed by other pharmaceutical companies using the same API supplier may also be affected.

Lots Under Voluntary Recall
The products that are part of this voluntary recall and listed below are packed in bottles. These lots were distributed nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VA Pharmacy, et. al).


Lot #

Exp. Date

Product Description / Strength

Bottle Size

NDC

23X017

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

90 Count

0093-7690-98

23X018

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

30 Count

0093-7690-56

23X018

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

90 Count

0093-7690-98

23X019

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

30 Count

0093-7690-56

23X019

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

90 Count

0093-7690-98

23X020

11/2018

Amlodipine and Valsartan Tablets
5 mg/160 mg

30 Count

0093-7690-56

23X022

4/2019

Amlodipine and Valsartan Tablets
5 mg/160 mg

30 Count

0093-7690-56

23X023

4/2019

Amlodipine and Valsartan Tablets
5 mg/160 mg

30 Count

0093-7690-56

23X023

4/2019

Amlodipine and Valsartan Tablets
5 mg/160 mg

90 Count

0093-7690-98

23X024

4/2019

Amlodipine and Valsartan Tablets
5 mg/160 mg

90 Count

0093-7690-98

 

 

 

 

 

24X012

11/2018

Amlodipine and Valsartan Tablets
10 mg/160 mg

30 Count

0093-7691-56

24X012

11/2018

Amlodipine and Valsartan Tablets
10 mg/160 mg

90 Count

0093-7691-98

24X013

11/2018

Amlodipine and Valsartan Tablets
10 mg/160 mg

30 Count

0093-7691-56

25X028

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

90 Count

0093-7692-98

25X029

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

25X029

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

90 Count

0093-7692-98

25X030

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

25X031

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

25X032

11/2018

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

25X035

4/2019

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

25X037

4/2019

Amlodipine and Valsartan Tablets
5 mg/320 mg

30 Count

0093-7692-56

26X036

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

90 Count

0093-7693-98

26X038

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

90 Count

0093-7693-98

26X039

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X039

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

90 Count

0093-7693-98

26X040

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X041

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X042

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X043

11/2018

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X044

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

90 Count

0093-7693-98

26X045

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

90 Count

0093-7693-98

26X046

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X047

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X048

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X049

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X050

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

26X051

4/2019

Amlodipine and Valsartan Tablets
10 mg/320 mg

30 Count

0093-7693-56

18X010

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

30 count

0093-7807-56

18X010

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

90 count

0093-7807-98

18X011

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

30 count

0093-7807-56

20X006

11/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg

30 count

0093-7810-56

20X006

11/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg

90 count

0093-7810-98

21X006

11/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg

30 count

0093-7038-56

21X006

11/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg

90 count

0093-7038-98

21X007

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg

30 count

0093-7038-56

22X045

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 count

0093-7809-56

22X045

2/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

90 count

0093-7809-98

22X046

02/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 count

0093-7809-56

22X047

02/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 count

0093-7809-56