Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (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, which corresponds to a Severe rating under the rubric. The presence of NDEA, a potential carcinogen, above acceptable levels represents a significant health risk, though no specific injuries or deaths are reported in the source text.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling 2,177 bottles of Irbesartan and Hydrochlorothiazide tablets, USP 150/12.5 mg, 90-count. The product is distributed nationwide under NDC 43547-330-09. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
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.
Patients currently taking this medication should contact their healthcare provider for guidance on alternative treatments. Consumers should not return the medication to the pharmacy unless instructed to do so by their healthcare provider or the recalling firm.
The recalled product
- Product
- IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,177
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)
- 325B18004
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
- 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
- LowPrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error
FDA (Drugs) · 2016-06-29
- LowTeva Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Errors
FDA (Drugs) · 2015-12-23
Same manufacturer · Prinston Pharmaceutical Inc
See all →- SeverePrinston Recalls Irbesartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
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FDA (Drugs) · 2018-08-01
- SeverePrinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01
- SeverePrinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01
Same hazard · nde contamination
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FDA (Drugs) · 2019-03-27
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FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23