US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk

      Summary Company Announcement Date: September 25, 2023 FDA Publish Date: … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

March 1, 2019 By The FDA Leave a Comment

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which 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 as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC.  To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP and Valsartan Tablets USP 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. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Name and strength Count Lot number Expiry

ACETRIS LOTS

52343-122-30 Valsartan Tablets USP 40mg 30 470170038A 19-Oct
52343-122-30 Valsartan Tablets USP 40mg 30 470180010A 20-Feb
52343-122-30 Valsartan Tablets USP 40mg 30 470180012A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471170019A 19-Oct
52343-123-90 Valsartan Tablets USP 80mg 90 471180006A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180007A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180016A 20-May
52343-124-90 Valsartan Tablets USP 160mg 90 472180005B 20-Feb
52343-124-90 Valsartan Tablets USP 160mg 90 472180011A 20-Apr
52343-124-90 Valsartan Tablets USP 160mg 90 472180012A 20-Apr
52343-125-90 Valsartan Tablets USP 320mg 90 473180007A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180008A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180011A 20-Apr
52343-125-90 Valsartan Tablets, USP 320mg 90 473180020B1 20-Jul

AUROBINDO LOTS

65862-570-30 Valsartan Tablets USP 40mg 30 470180008A 20-Feb
65862-570-30 Valsartan Tablets USP 40mg 30 470180014A 20-Mar
65862-570-30 Valsartan Tablets USP 40mg 30 470180016A 20-Mar
65862-571-90 Valsartan Tablets USP 80mg 90 471170015A 19-Sep
65862-571-90    Valsartan Tablets USP 80mg 90 471180004A 20-Feb
65862-571-90    Valsartan Tablets USP 80mg 90 471180005A 20-Feb
65862-572-90    Valsartan Tablets USP 160mg 90 472180001A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180002A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180003A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180004A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180007A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180008A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180009A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180010A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180013A 20-Apr
65862-572-90    Valsartan Tablets USP 160mg 90 472180014A 20-Apr
65862-573-90    Valsartan Tablets USP 320mg 90 473180004A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180005A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180006A 20-Mar
65862-573-90    Valsartan Tablets USP 320mg 90 473180017A 20-May
65862-739-30    Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17007-A 19-Oct
65862-570-30 Valsartan Tablets, USP 40mg 30 470180032A 20-May
65862-573-90 Valsartan Tablets, USP 320mg 90 473170019A 19-Oct
65862-573-90 Valsartan Tablets, USP 320mg 90 473180016A 20-May

Amlodipine Valsartan Tablets USP and Valsartan Tablets USP were distributed nationwide to AurobindoPharma USA, Inc. and Aceteris Health LLC wholesale, distributor, repackager and retail customers. AurobindoPharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. AurobindoPharma USA, Inc. is arranging for return of all recalled products to Inmar. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact AurobindoPharma USA, Inc. at:

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact InmarCLS-Medturn at 1-877-208-2407 or email [email protected]  (live calls received 9 am -5:00 pm Eastern Time).

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk

September 24, 2023 By The FDA

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023 By The FDA

TAMA Corporation Emite Un Alerta De Alergenos No Declarados: Trigo, Soya y Amarillo #5 En Las “Cachapas De Maiz Paisa”

September 21, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Make Believe Ideas Recalls Seven Rainbow Road Board Books Due to Choking Hazard

September 20, 2023 By The CPSC

H&M Recalls Men’s Clasp Beaded Bracelets Due to Lead Poisoning Hazard; High Levels of Lead Content

September 20, 2023 By The CPSC

FXI Recalls Novaform ComfortGrande and DreamAway Mattresses Due to Risk of Mold Exposure; Sold Exclusively at Costco (Recall Alert)

September 20, 2023 By The CPSC

DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard

September 20, 2023 By The CPSC

Shimano Recalls Cranksets for Bicycles Due to Crash Hazard

September 20, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard

September 20, 2023 By The CPSC

Shimano Recalls Cranksets for Bicycles Due to Crash Hazard

September 20, 2023 By The CPSC

Life Raft Treats has Expanded their Recalls of Ice Cream Products, Not Fried Chicken And Life Is Peachy, Due to Possible Listeria Monocytogenes Contamination

September 18, 2023 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk
  • VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
  • TAMA Corporation Emite Un Alerta De Alergenos No Declarados: Trigo, Soya y Amarillo #5 En Las “Cachapas De Maiz Paisa”
  • TAMA Corporation Issues Allergy Alert for Undeclared Wheat, Soy and Yellow #5 in “Cachapas de Maiz PAISA”
  • HONEY JOY Recalls Infant Swings Due to Suffocation Hazard and Violation of Federal Safety Standards; Sold Exclusively on Amazon.com
  • Make Believe Ideas Recalls Seven Rainbow Road Board Books Due to Choking Hazard
  • H&M Recalls Men’s Clasp Beaded Bracelets Due to Lead Poisoning Hazard; High Levels of Lead Content
  • FXI Recalls Novaform ComfortGrande and DreamAway Mattresses Due to Risk of Mold Exposure; Sold Exclusively at Costco (Recall Alert)
  • DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2023 Altrumedia · Terms of Service · Log in