Safety

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.

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.

For Immediate Release

March 1, 2019

Contact

Consumers

AurobindoPharma USA, Inc.
pvg@aurobindousa.com
1-866-850-2876 Option 2

Media

Inmar\CLS-Medturn
aurobindorecalls@inmar.com
1-877-208-2407

Announcement

AurobindoPharma USA, Inc. and Acetris Health LLC. Are conducting a voluntary recall expansion of 39 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
52343-125-90 Valsartan Tablets, USP 320mg 90 473170019B 19-Oct

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 Inmar\CLS-Medturn at 1-877-208-2407 or email aurobindorecalls@inmar.com  (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.

###

Product Photos

  • Valsartan Tablets USP, 40 mg, 30 Tablets, Acetris 
  • Valsartan Tablets USP, 80 mg, 90 Tablets, Acetris 
  • Valsartan Tablets USP, 160 mg, 90 Tablets, Acetris 
  • Valsartan Tablets USP, 320 mg, 90 Tablets, Acetris 
  • Valsartan Tablets USP, 40 mg, 30 Tablets, Aurobindo 
  • Valsartan Tablets USP, 80 mg, 90 Tablets, Aurobindo 
  • Valsartan Tablets USP,160 mg, 90 Tablets, Aurobindo 
  • Valsartan Tablets USP, 320 mg, 90 Tablets, Aurobindo 
  • Amlodipine and Valsartan Tablets USP, 10 mg-160 gm, 30 Tablets, Aurobindo 

Page Last Updated: 03/12/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English