Irbesartan Tablet
FDA Recall NDC 43547-375
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Irbesartan (NDC 43547-375). A significant event, classified as Class II, was initiated on Jan 18, 2019 by Solco Healthcare U.s., Llc. The reported reason for this action was: "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Jan 18, 2019
Feb 06, 2019
19800 bottles
Recall Profile & Regulatory Data
Event ID
81910
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Batch or Lot Expiration Information
Lot# 331B18009
Affected Packages Involved in this Recall
43547-374-03Product
43547-374-09Product
43547-374-50Product
43547-375-03Product
43547-375-09Product
43547-375-50Product
43547-376-03Product
43547-376-09Product
43547-376-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
