Irbesartan And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 0093-8232
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 And Hydrochlorothiazide (NDC 0093-8232). A significant event, classified as Class III, was initiated on Oct 20, 2015 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot AND/OR Exp Date."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Oct 20, 2015
Dec 23, 2015
3536 bottles
Recall Profile & Regulatory Data
Event ID
72607
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceutical Industries
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 01, 2016
Product Description
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98
Batch or Lot Expiration Information
Lot# : 24I030, Exp 5/2017
Affected Packages Involved in this Recall
0093-8238-56Product
0093-8238-98Product
0093-8232-56Product
0093-8232-98Product
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.
