Camber and NuCare – Recall of Valsartan

Camber and NuCare ? Recall of Valsartan

? On August 9, 2018, the FDA announced an update to the list of valsartan products under recall and the list of valsartan products not under recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.

? Camber Pharmaceuticals announced the voluntary recall of certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals.

? The update includes the following recalled products:

Manufacturer

Product Description

NDC #

Camber NuCare

Valsartan 40 mg tablets

Valsartan 80 mg tablets Valsartan 160 mg tablets Valsartan 320 mg tablets Valsartan-HCTZ 160 mg/12.5 mg tablets Valsartan-HCTZ 160 mg/25 mg tablets Valsartan-HCTZ 320 mg/25 mg tablets

31722-745-30 31722-746-90 31722-747-90 31722-748-90 68071-4311-9

68071-2119-3

68071-4183-3

Lot # (Expiration Date)

All lots (7/2018 ? 6/2020)

UO1779 (4/2019) T11443 (2/2019) T11577 (6/2019)

? Valsartan is a medication commonly used to treat high blood pressure and heart failure.

? Test results from Hetero Labs showed that the amount of NDMA found in its valsartan API exceeds acceptable levels. The amount was generally lower than the amount discovered in the API manufactured by Zhejiang.

? The FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation. The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API.

? The recalled valsartan products labeled as Camber may be repackaged by other companies. The FDA will provide updates as more information becomes available.

? NDMA is classified as a probable human carcinogen by the U.S. Environmental Protection Agency. The presence of NDMA was unexpected in the recalled valsartan products and is thought to be related to changes in the way the active substance was manufactured.

-- NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in the recalled valsartan batches.

-- NDMA is found in some water supplies and in some foods. Consuming up to 96 nanograms NDMA/day is considered reasonably safe for human ingestion.

Continued . . .

-- It is estimated that over the course of a person's lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetime.

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

? For Camber products, patients with questions regarding this recall can contact Qualanex by phone at 1-800-505-9291 or email recall@. For NuCare products, patients can contact NuCare at 1-888-482-9545.

? Patients should contact their healthcare provider if they have experienced any problems that might be related to taking or using the recalled valsartan.

? On July 13th, the FDA initiated a series of announcements regarding the recall of certain batches of valsartan and valsartan-hydrochlorothiazide (HCTZ) tablets because of unacceptable levels of NDMA.

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