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Drug recall · FDA · Published July 13, 2018

Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only,

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

🇺🇸 FDA recall #D-0974-2018DrugPrinston Pharmaceutical Inc ›
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Recalling firmPrinston Pharmaceutical Inc2002 Eastpark Blvd, N/A · Cranbury, NJ 08512-3514
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/40366-prinston-pharmaceutical-inc-recalls-solco-healthcare-us-valsartan-and-hydrochlorothiazide · Recall date July 13, 2018 · FDA enforcement record: FDA #D-0974-2018

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“Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only,.” GovInfoNow, recall dated July 13, 2018. https://govinfonow.com/recall/40366-prinston-pharmaceutical-inc-recalls-solco-healthcare-us-valsartan-and-hydrochlorothiazide. Based on FDA recall #D-0974-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2018%22&limit=1).

How to tell if you have this one

  • Brand
    Prinston Pharmaceutical Inc
  • Category
    Drug
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    United States
Recall numberProduct, codes & lotsNDC
D-0968-2018Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- 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 43547-367-03; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0969-2018Solco Healthcare US Valsartan, USP, 80 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 43547-368-09; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0970-2018Solco Healthcare US Valsartan, USP, 160 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 43547-369-09; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0971-2018Solco 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; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0972-2018Solco 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; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0973-2018Solco 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; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0974-2018Solco 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; All lots within expiry43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0975-2018Solco 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; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0976-2018Solco 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; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
Take action

Contact Prinston Pharmaceutical Inc

We’ve drafted a message you can send Prinston Pharmaceutical Inc to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-0974-2018 — Prinston Pharmaceutical Inc Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and H

Hello,

I own a Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, that is covered by recall D-0974-2018 from Prinston Pharmaceutical Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx
A-S Medication Solutions LLC · 90% matchPreferred Pharmaceuticals, Inc recalls Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250
Preferred Pharmaceuticals, Inc. · 89% matchTeva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only,
Teva Pharmaceuticals USA · 89% matchMAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC#
MAJOR PHARMACEUTICALS · 88% matchRemedyRepack Inc. recalls Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA
RemedyRePack Inc. · 88% match

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0974-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0974-2018 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA