Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc. is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a carcinogen impurity, which poses a significant health risk consistent with the 'Severe' rubric criteria for significant injury or high-risk contamination.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling Valsartan (Valsartan) tablets, 320 mg, 90-count bottles. The product is distributed by Solco Healthcare US, LLC and manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. The recall covers all lots within expiry.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.
Consumers and healthcare providers should stop using the recalled Valsartan tablets and contact their healthcare provider for alternative treatment options. The product is distributed in the United States.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
UPCs (7)
- 0343547370039
- 0343547369033
- 0343547368098
- 0343547370091
- 0343547367039
- 0343547368036
- 0343547369095
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Prinston Pharmaceutical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
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Same manufacturer · Prinston Pharmaceutical Inc
See all →- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
Same hazard · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12