FDA Drug recall D-0361-2019
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
- FDA Drug
- Class II
- ongoing
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810 by Aurobindo Pharma Usa, citing CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily inta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0361-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-31 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Identifiers
| ndc | 65862-737-30 |
|---|---|
| ndc | 65862-737-90 |
| ndc | 65862-737-10 |
| ndc | 65862-737-03 |
| ndc | 65862-739-30 |
| ndc | 65862-739-90 |
| ndc | 65862-739-10 |
| ndc | 65862-739-03 |
| ndc | 65862-738-30 |
| ndc | 65862-738-90 |
| ndc | 65862-738-10 |
| ndc | 65862-738-03 |
| ndc | 65862-740-30 |
| ndc | 65862-740-90 |
| ndc | 65862-740-10 |
| ndc | 65862-740-03 |
| code_info | Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0361-2019%22
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