FDA Drug recall D-0971-2018
Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd
- FDA Drug
- Class II
- ongoing
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd by Prinston Pharmaceutical, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0971-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-13 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Prinston Pharmaceutical |
| Distribution | n/a |
Product
Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| ndc | 43547-367-03 |
|---|---|
| ndc | 43547-367-09 |
| ndc | 43547-367-50 |
| ndc | 43547-367-11 |
| ndc | 43547-368-03 |
| ndc | 43547-368-09 |
| ndc | 43547-368-50 |
| ndc | 43547-368-11 |
| ndc | 43547-369-03 |
| ndc | 43547-369-09 |
| ndc | 43547-369-50 |
| ndc | 43547-369-11 |
| ndc | 43547-370-03 |
| ndc | 43547-370-09 |
| ndc | 43547-370-50 |
| ndc | 43547-370-11 |
| code_info | All lots within expiry. |
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-0971-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.