The Recall Desk
SevereFDA (Drugs)·D-0411-2019·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 testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

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, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

Prinston Pharmaceutical Inc. is recalling 32,692 bottles of Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg. The product is distributed nationwide under NDC 43547-331-03. The recall is limited to specific lot codes 327A18001 and 327A18002.

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 detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million.

Consumers and healthcare providers should check their inventory for the specific lot codes listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

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
32,692

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)

  • 327A18001 327A18002

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 →

Related recalls

Same brand · IRBESARTAN AND HYDROCHLOROTHIAZIDE

Same manufacturer · Prinston Pharmaceutical Inc

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Same hazard · nde contamination

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