The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0973-2018·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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that a 'Carcinogen impurity' was detected. Under the severity rubric, the presence of a carcinogen in a drug product constitutes a significant injury risk, aligning with the 'Severe' classification (Score 4) for significant injury reports or high-risk hazards, even though the agency classified it as Class II.

Plain-English summary

Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets, USP, 160 mg/12.5 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 the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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

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