Breaking News
May 3, 2019 - Vaping and Smoking May Signal Greater Motivation to Quit
May 3, 2019 - Dementia looks different in brains of Hispanics
May 3, 2019 - Short-Staffed Nursing Homes See Drop In Medicare Ratings
May 3, 2019 - Study of teens with eating disorders explores how substance users differ from non-substance users
May 3, 2019 - Scientists develop new video game that may help in the study of Alzheimer’s
May 3, 2019 - Arc Bio introduces Galileo Pathogen Solution product line at ASM Clinical Virology Symposium
May 3, 2019 - Cornell University study uncovers relationship between starch digestion gene and gut bacteria
May 3, 2019 - How to Safely Use Glucose Meters and Test Strips for Diabetes
May 3, 2019 - Anti-inflammatory drugs ineffective for prevention of Alzheimer’s disease
May 3, 2019 - Study tracks Pennsylvania’s oil and gas waste-disposal practices
May 3, 2019 - Creating a better radiation diagnostic test for astronauts
May 3, 2019 - Vegans are often deficient in these four nutrients
May 3, 2019 - PPDC announces seed grants to develop medical devices for children
May 3, 2019 - Study maps out the frequency and impact of water polo head injuries
May 3, 2019 - Research on Reddit identifies risks associated with unproven treatments for opioid addiction
May 3, 2019 - Good smells may help ease tobacco cravings
May 3, 2019 - Medical financial hardship found to be very common among people in the United States
May 3, 2019 - Researchers develop multimodal system for personalized post-stroke rehabilitation
May 3, 2019 - Study shows significant mortality benefit with CABG over percutaneous coronary intervention
May 3, 2019 - Will gene-editing of human embryos ever be justifiable?
May 3, 2019 - FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
May 3, 2019 - Why Tonsillitis Keeps Coming Back
May 3, 2019 - Fighting the opioid epidemic with data
May 3, 2019 - Maggot sausages may soon be a reality
May 3, 2019 - Deletion of ATDC gene prevents development of pancreatic cancer in mice
May 2, 2019 - Targeted Therapy Promising for Rare Hematologic Cancer
May 2, 2019 - Alzheimer’s disease is a ‘double-prion disorder,’ study shows
May 2, 2019 - Reservoir bugs: How one bacterial menace makes its home in the human stomach
May 2, 2019 - Clinical, Admin Staff From Cardiology Get Sneak Peek at Epic
May 2, 2019 - Depression increases hospital use and mortality in children
May 2, 2019 - Vicon and NOC support CURE International to create first gait lab in Ethiopia
May 2, 2019 - Researchers use 3D printer to make paper organs
May 2, 2019 - Viral infection in utero associated with behavioral abnormalities in offspring
May 2, 2019 - U.S. Teen Opioid Deaths Soaring
May 2, 2019 - Opioid distribution data should be public
May 2, 2019 - In the Spotlight: “I’m learning every single day”
May 2, 2019 - 2019 Schaefer Scholars Announced
May 2, 2019 - Podcast: KHN’s ‘What The Health?’ Bye-Bye, ACA, And Hello ‘Medicare-For-All’?
May 2, 2019 - Study describes new viral molecular evasion mechanism used by cytomegalovirus
May 2, 2019 - SLU study suggests a more equitable way for Medicare reimbursement
May 2, 2019 - Scientists discover first gene involved in lower urinary tract obstruction
May 2, 2019 - Researchers identify 34 genes associated with increased risk of ovarian cancer
May 2, 2019 - Many low-income infants receive formula in the first few days of life, finds study
May 2, 2019 - Global study finds high success rate for hip and knee replacements
May 2, 2019 - Taking depression seriously: What is it?
May 2, 2019 - With Head Injuries Mounting, Will Cities Put Their Feet Down On E-Scooters?
May 2, 2019 - Scientists develop small fluorophores for tracking metabolites in living cells
May 2, 2019 - Study casts new light into how mothers’ and babies’ genes influence birth weight
May 2, 2019 - Researchers uncover new brain mechanisms regulating body weight
May 2, 2019 - Organ-on-chip systems offered to Asia-Pacific regions by Sydney’s AXT
May 2, 2019 - Adoption of new rules drops readmission penalties against safety net hospitals
May 2, 2019 - Kids and teens who consume zero-calorie sweetened beverages do not save calories
May 2, 2019 - Improved procedure for cancer-related erectile dysfunction
May 2, 2019 - Hormone may improve social behavior in autism
May 2, 2019 - Alzheimer’s disease may be caused by infectious proteins called prions
May 2, 2019 - Even Doctors Can’t Navigate Our ‘Broken Health Care System’
May 2, 2019 - Study looks at the impact on criminal persistence of head injuries
May 2, 2019 - Honey ‘as high in sugars as table sugar’
May 2, 2019 - Innovations to U.S. food system could help consumers in choosing healthy foods
May 2, 2019 - FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
May 2, 2019 - Women underreport prevalence and intensity of their own snoring
May 2, 2019 - Concussion summit focuses on science behind brain injury
May 2, 2019 - Booker’s Argument For Environmental Justice Stays Within The Lines
May 2, 2019 - Cornell research explains increased metastatic cancer risk in diabetics
May 2, 2019 - Mount Sinai study provides fresh insights into cellular pathways that cause cancer
May 2, 2019 - Researchers to study link between prenatal pesticide exposures and childhood ADHD
May 2, 2019 - CoGEN Congress 2019: Speakers’ overviews
May 2, 2019 - A new strategy for managing diabetic macular edema in people with good vision
May 2, 2019 - Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance
May 2, 2019 - Screen time associated with behavioral problems in preschoolers
May 2, 2019 - Hormone reduces social impairment in kids with autism | News Center
May 2, 2019 - Researchers synthesize peroxidase-mimicking nanozyme with low cost and superior catalytic activity
May 2, 2019 - Study results of a potential drug to treat Type 2 diabetes in children announced
May 2, 2019 - Multigene test helps doctors to make effective treatment decisions for breast cancer patients
May 2, 2019 - UNC School of Medicine initiative providing unique care to dementia patients
May 2, 2019 - Nestlé Health Science and VHP join forces to launch innovative COPES program for cancer patients
May 2, 2019 - Study examines how our brain generates consciousness and loses it during anesthesia
May 2, 2019 - Transition Support Program May Aid Young Adults With Type 1 Diabetes
May 2, 2019 - Study shows how neutrophils exacerbate atherosclerosis by inducing smooth muscle-cell death
May 2, 2019 - Research reveals complexity of how we make decisions
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 USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

November 27, 2018

Audience: Consumer, Health Professional, Pharmacy

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 30 Count 0093-7693-56
Lot # Exp. Date Product Description / Strength Bottle Size NDC
    10 mg/320 mg    
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
Lot # Exp. Date Product Description/ Strength Bottle Size NDC
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

Source: FDA

About author

Related Articles