CLASS II ONGOING Drug recall · Reported 1 Aug 2018 · FDA Enforcement Report
Solco Healthcare US Valsartan and Hydrochlorothiazide recalled
Prinston Pharmaceutical is recalling Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0973-2018
- FDA event ID
- 80525
- Recalling firm
- Prinston Pharmaceutical, Cranbury, NJ
- Manufacturer
- Solco Healthcare US, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2018
- FDA classified
- 20 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 13 Jul 2018 | Recall initiated by company | |
| 20 Jul 2018 | Classified by FDA | +7 days |
| 1 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
United States
Questions about this recall
Is Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12 recalled?
Yes. Prinston Pharmaceutical recalled Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12 on 13 Jul 2018. The recall is Class II and its status is Ongoing. Recall number D-0973-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
All lots within expiry.
Where was it sold?
United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Prinston Pharmaceutical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Valsartan recalls
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |