The Recall Desk
SevereFDA (Drugs)·D-0972-2018·Announced 2018-08-01

Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide 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 the detection of a carcinogen impurity in a prescription drug represents a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets, 80 mg/12.5 mg, 90-count bottles. The product is distributed by Solco Healthcare US, LLC and manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. in China.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The recall covers all lots within expiry.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options. The product is available in the United States.

The recalled product

Product
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Brand
VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Prinston Pharmaceutical Inc
Category
Drug — Prescription Medication
Hazard

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 (10)

  • 0343547315092
  • 0343547314095
  • 0343547313036
  • 0343547315030
  • 0343547312091
  • 0343547311032
  • 0343547314033
  • 0343547312039
  • 0343547311094
  • 0343547313098

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 AND HYDROCHLOROTHIAZIDE

Same manufacturer · Prinston Pharmaceutical Inc

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Same hazard · carcinogen impurity

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