U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)
  1. Safety

COMPANY ANNOUNCEMENT

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

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.

Read Announcement

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Summary

Company Announcement Date:
August 08, 2018
FDA Publish Date:
August 09, 2018
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity
Company Name:
Camber Pharmaceuticals, Inc.
Brand Name:
Brand Name(s)
Camber Pharmaceuticals, Inc.
Product Description:
Product Description
Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg

Company Announcement

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level.  This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer), as per International Agency for Research on Cancer (IARC) classification.  To date, Camber has not received any reports of adverse events related to this recall.

Valsartan Tablets, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles & 90ct bottles, all associated codes are provided in the table below with lot # and expiration dates.

Product Description NDC Number Batches Exp. Date
Valsartan Tablets USP, 40mg 31722-745-30 All lots 07/2018 - 06/2020
Valsartan Tablets USP, 80mg 31722-746-90 All lots 07/2018 - 06/2020
Valsartan Tablets USP, 160mg 31722-747-90 All lots 07/2018 - 06/2020
Valsartan Tablets USP, 320mg 31722-748-90 All lots 07/2018 - 06/2020

Valsartan Tablets were distributed Nationwide to Wholesalers, Distributors, Hospitals and Retail Pharmacies and Mail Order Pharmacies.

Qualanex, LLC will be notifying Camber’s distributors and other customers by recall letter and arranging for return of all recalled products.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this product. Pharmacies and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Qualanex, LLC by phone at 1-800-505-9291 or email recall@qualanex.com from Monday to Friday between 9am – 5pm Central Time.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.


Company Contact Information

Consumers:
Qualanex Customer Service - Recalls
1-800-505-9291
recall@qualanex.com