Solco Healthcare US Valsartan and Hydrochlorothiazide — Class II drug recall D-0972-2018
Ongoing recall by Prinston Pharmaceutical Inc, reported 2018-08-01. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-0972-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prinston Pharmaceutical Inc, Cranbury, NJ, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Reason classes | cgmp, specification failure |
| NDC | 43547-0311, 43547-0311-03, 43547-0311-09, 43547-0311-50, 43547-0312, 43547-0312-03, 43547-0312-09, 43547-0312-50, 43547-0313, 43547-0313-03, 43547-0313-09, 43547-0313-50, 43547-0314, 43547-0314-03, 43547-0314-09, 43547-0314-50, 43547-0315, 43547-0315-03, 43547-0315-09, 43547-0315-50 |
Product
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, 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 43547-311-09
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.