The Recall Desk
SevereFDA (Drugs)·D-0413-2019·Announced 2019-02-06

Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.

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. Per the rubric, FDA Class II recalls with significant injury/property-damage reports or hospitalization reports are Severe. While no specific injuries are reported in the text, the presence of a carcinogenic impurity (NDEA) above acceptable limits in a prescription drug typically warrants a Severe classification under the 'significant injury' or high-risk criteria for Class II drug recalls involving impurities.

Plain-English summary

Prinston Pharmaceutical Inc is recalling 87,505 bottles of Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg. The affected product is distributed nationwide and includes bottles with lot codes 325D18004 and 325D18005. The product is manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. and distributed by Solco Healthcare US, LLC.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Brand
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Prinston Pharmaceutical Inc
Category
Drug — Prescription Drug
Hazard
Affected units
87,505

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)

  • 325D18004 325D18005

UPCs (2)

  • 0343547331030
  • 0343547330033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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Same brand · IRBESARTAN AND HYDROCHLOROTHIAZIDE

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Same hazard · nde impurity

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