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 NDEA above acceptable limits.
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, particularly given the presence of a carcinogenic impurity (NDEA) above acceptable limits.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling 12,294 bottles of Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg. The affected product is distributed nationwide and is identified by NDC 43547-331-09 and lot codes 327B18008 and 327B18009.
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 stop using the recalled product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Drug
- Affected units
- 12,294
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)
- 327B18008 327B18009
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
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Same manufacturer · Prinston Pharmaceutical Inc
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