Market Overview

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg.


Company Contact: Qualanex, LLC.
Name: Qualanex
Customer Service - Recalls
Phone Number: 1-800-505-9291

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

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
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.

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