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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 Impurity

Audience: Consumer, Health Professional, Pharmacy

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 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.

NDCName and strengthCountLot numberExpiry

ACETRIS LOTS

52343-122-30Valsartan Tablets USP 40mg30470170038A19-Oct
52343-122-30Valsartan Tablets USP 40mg30470180010A20-Feb
52343-122-30Valsartan Tablets USP 40mg30470180012A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471170019A19-Oct
52343-123-90Valsartan Tablets USP 80mg90471180006A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471180007A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471180016A20-May
52343-124-90Valsartan Tablets USP 160mg90472180005B20-Feb
52343-124-90Valsartan Tablets USP 160mg90472180011A20-Apr
52343-124-90Valsartan Tablets USP 160mg90472180012A20-Apr
52343-125-90Valsartan Tablets USP 320mg90473180007A20-Mar
52343-125-90Valsartan Tablets USP 320mg90473180008A20-Mar
52343-125-90Valsartan Tablets USP 320mg90473180011A20-Apr
52343-125-90Valsartan Tablets, USP 320mg90473180020B120-Jul

AUROBINDO LOTS

65862-570-30Valsartan Tablets USP 40mg30470180008A20-Feb
65862-570-30Valsartan Tablets USP 40mg30470180014A20-Mar
65862-570-30Valsartan Tablets USP 40mg30470180016A20-Mar
65862-571-90Valsartan Tablets USP 80mg90471170015A19-Sep
65862-571-90Valsartan Tablets USP 80mg90471180004A20-Feb
65862-571-90Valsartan Tablets USP 80mg90471180005A20-Feb
65862-572-90Valsartan Tablets USP 160mg90472180001A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180002A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180003A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180004A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180007A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180008A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180009A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180010A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180013A20-Apr
65862-572-90Valsartan Tablets USP 160mg90472180014A20-Apr
65862-573-90Valsartan Tablets USP 320mg90473180004A20-Feb
65862-573-90Valsartan Tablets USP 320mg90473180005A20-Feb
65862-573-90Valsartan Tablets USP 320mg90473180006A20-Mar
65862-573-90Valsartan Tablets USP 320mg90473180017A20-May
65862-739-30Amlodipine and Valsartan Tablets USP 10mg/160mg30VFSA17007-A19-Oct
65862-570-30Valsartan Tablets, USP 40mg30470180032A20-May
65862-573-90Valsartan Tablets, USP 320mg90473170019A19-Oct
65862-573-90Valsartan Tablets, USP 320mg90473180016A20-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.

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