Irbesartan And Hydrochlorothiazide Tablet
FDA Recall NDC 43547-331
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Irbesartan And Hydrochlorothiazide (NDC 43547-331). A significant event, classified as Class II, was initiated on Jan 18, 2019 by Solco Healthcare Us, 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
87505 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 and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
Batch or Lot Expiration Information
Lot# 325D18004 325D18005
Affected Packages Involved in this Recall
43547-330-03Product
43547-330-09Product
43547-330-50Product
43547-331-03Product
43547-331-09Product
43547-331-50Product
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
2177 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 and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09
Batch or Lot Expiration Information
Lot# 325B18004
Affected Packages Involved in this Recall
43547-330-03Product
43547-330-09Product
43547-330-50Product
43547-331-03Product
43547-331-09Product
43547-331-50Product
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
32692 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 and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03
Batch or Lot Expiration Information
Lot# 327A18001 327A18002
Affected Packages Involved in this Recall
43547-330-03Product
43547-330-09Product
43547-330-50Product
43547-331-03Product
43547-331-09Product
43547-331-50Product
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
12294 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 and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
Batch or Lot Expiration Information
Lot# 327B18008 327B18009
Affected Packages Involved in this Recall
43547-330-03Product
43547-330-09Product
43547-330-50Product
43547-331-03Product
43547-331-09Product
43547-331-50Product
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
May 30, 2016
Jun 29, 2016
60 bottles (5 cases)
Recall Profile & Regulatory Data
Event ID
74423
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Prinston Pharmaceutical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 09, 2017
Product Description
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
Batch or Lot Expiration Information
Lot# : 327B16002, Exp 12/17
Affected Packages Involved in this Recall
43547-330-03Product
43547-330-09Product
43547-330-50Product
43547-331-03Product
43547-331-09Product
43547-331-50Product
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.
