Prinston Recalls Irbesartan Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.
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 and involves a known carcinogenic impurity (NDEA) exceeding safety limits, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling 19,800 bottles of Irbesartan 300 mg tablets (NDC 43547-376-09). The product is distributed nationwide and was manufactured by Zhejiang Huahai Pharmaceutical Co. in China and distributed by Solco Healthcare US, LLC in Cranbury, NJ.
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.
Patients who have been prescribed this specific lot of Irbesartan should contact their healthcare provider for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- IRBESARTAN (IRBESARTAN)
- Brand
- IRBESARTAN
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Drug
- Affected units
- 19,800
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)
- 331B18009
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
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