Valsartan And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 43547-313
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Valsartan And Hydrochlorothiazide (NDC 43547-313). A significant event, classified as Class II, was initiated on Jul 13, 2018 by Solco Healthcare Us, Llc. The reported reason for this action was: "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 13, 2018
Aug 01, 2018
N/A
Recall Profile & Regulatory Data
Event ID
80525
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Product Description
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 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 43547-314-09
Batch or Lot Expiration Information
Lot# All lots within expiry.
Affected Packages Involved in this Recall
43547-311-03Product
43547-311-09Product
43547-311-50Product
43547-312-03Product
43547-312-09Product
43547-312-50Product
43547-313-03Product
43547-313-09Product
43547-313-50Product
43547-314-03Product
43547-314-09Product
43547-314-50Product
43547-315-03Product
43547-315-09Product
43547-315-50Product
Class II Ongoing
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 13, 2018
Aug 01, 2018
N/A
Recall Profile & Regulatory Data
Event ID
80525
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Product Description
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 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 43547-315-09
Batch or Lot Expiration Information
Lot# All lots within expiry.
Affected Packages Involved in this Recall
43547-311-03Product
43547-311-09Product
43547-311-50Product
43547-312-03Product
43547-312-09Product
43547-312-50Product
43547-313-03Product
43547-313-09Product
43547-313-50Product
43547-314-03Product
43547-314-09Product
43547-314-50Product
43547-315-03Product
43547-315-09Product
43547-315-50Product
Class II Ongoing
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 13, 2018
Aug 01, 2018
N/A
Recall Profile & Regulatory Data
Event ID
80525
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Product Description
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 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 43547-312-09
Batch or Lot Expiration Information
Lot# All lots within expiry.
Affected Packages Involved in this Recall
43547-311-03Product
43547-311-09Product
43547-311-50Product
43547-312-03Product
43547-312-09Product
43547-312-50Product
43547-313-03Product
43547-313-09Product
43547-313-50Product
43547-314-03Product
43547-314-09Product
43547-314-50Product
43547-315-03Product
43547-315-09Product
43547-315-50Product
Class II Ongoing
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 13, 2018
Aug 01, 2018
N/A
Recall Profile & Regulatory Data
Event ID
80525
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Product Description
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 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 43547-313-09
Batch or Lot Expiration Information
Lot# All lots within expiry
Affected Packages Involved in this Recall
43547-311-03Product
43547-311-09Product
43547-311-50Product
43547-312-03Product
43547-312-09Product
43547-312-50Product
43547-313-03Product
43547-313-09Product
43547-313-50Product
43547-314-03Product
43547-314-09Product
43547-314-50Product
43547-315-03Product
43547-315-09Product
43547-315-50Product
Class II Ongoing
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 13, 2018
Aug 01, 2018
N/A
Recall Profile & Regulatory Data
Event ID
80525
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Product Description
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
Batch or Lot Expiration Information
Lot# All lots within expiry.
Affected Packages Involved in this Recall
43547-311-03Product
43547-311-09Product
43547-311-50Product
43547-312-03Product
43547-312-09Product
43547-312-50Product
43547-313-03Product
43547-313-09Product
43547-313-50Product
43547-314-03Product
43547-314-09Product
43547-314-50Product
43547-315-03Product
43547-315-09Product
43547-315-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
