FDA Drug recall D-0369-2019
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,…
- FDA Drug
- Class II
- ongoing
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,… 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-0369-2019 |
| 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
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
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 | 65862-547-90 |
|---|---|
| ndc | 65862-547-99 |
| ndc | 65862-547-10 |
| ndc | 65862-548-90 |
| ndc | 65862-548-99 |
| ndc | 65862-548-10 |
| ndc | 65862-549-90 |
| ndc | 65862-549-99 |
| ndc | 65862-549-10 |
| ndc | 65862-550-90 |
| ndc | 65862-550-05 |
| ndc | 65862-551-90 |
| ndc | 65862-551-05 |
| code_info | Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot #…Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020 |
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-0369-2019%22
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