Summary

Company Announcement Date: December 31, 2018 FDA Publish Date: December 31, 2018 Product Type: Drugs

Generic Drugs Reason for Announcement: Recall Reason Description Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo Product Description: Product Description Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP

Company Announcement

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. 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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP, Valsartan HCTZ 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, Valsartan HCTZ 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 65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17013-A 10/2019 65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17014-A 10/2019 65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18001-A 12/2019 65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18002-A 12/2019 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17008-A 10/2019 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17010-A 10/2019 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18002-A 01/2020 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18003-A 01/2020 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18007-A 03/2020 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18008-A 03/2020 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17008-A 05/2019 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17014-A 10/2019 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17015-A 10/2019 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17016-A 10/2019 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17017-A 10/2019 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18002-A 01/2020 65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18004-A 01/2020 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17012-A 11/2019 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17013-A 11/2019 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17014-A 11/2019 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17015-A 11/2019 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17016-A 11/2019 65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17017-A 11/2019 65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17009-A 10/2019 65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18005-A 03/2020 65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18001-A 01/2020 65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17033-A 10/2020 65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17034-A 10/2020 65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17035-A 10/2020 65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17036-A 10/2020 65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17037-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17033-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17034-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17035-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17036-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17040-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17041-A 11/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17042-A 11/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17043-A 11/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17049-A 08/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17054-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17055-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17056-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17057-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17058-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17059-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17060-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17062-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17066-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17067-A 11/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17068-A 11/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17069-A 11/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18001-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18002-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18003-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18004-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18005-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18006-A 12/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18007-A 12/2020 65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17011-A 11/2020 65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17012-A 11/2020 65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA18001-A 12/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17023-A 08/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17036-A 11/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17037-A 11/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17038-A 11/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17039-A 11/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17040-B 11/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18001-A 12/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18002-A 12/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18003-A 12/2020 65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18004-A 12/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17037-A 10/2020 65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17039-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17063-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17064-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17065-A 10/2020 65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP & 320/25mg 90 HTSB18029-A 03/2021 65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17008-A 07/2019 65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17009-A 09/2019

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma 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. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Inmar/CLS Medturn. 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 Aurobindo Pharma USA, Inc. at:

1-866-850-2876 Option 2

pvg@aurobindousa.com

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 rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information Consumers: Aurobindo Pharma USA 1-866-850-2876 Option 2 pvg@aurobindousa.com Media: Inmar\CLS-Medturn 1-877-208-2407 rxrecalls@inmar.com