Candesartan Cilexetil And Hydrochlorothiazide Tablet
FDA Recall NDC 0378-3003
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 Candesartan Cilexetil And Hydrochlorothiazide (NDC 0378-3003). A significant event, classified as Class III, was initiated on Oct 02, 2020 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Out-of-specification organic impurity results obtained during routine stability testing."
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
October 2020 Class III Recall: Out-of-specification organic impurity results obtained during routine stability testing.
Recall Number
Class III Terminated
Out-of-specification organic impurity results obtained during routine stability testing.
Oct 02, 2020
Oct 28, 2020
10,695 bottles
Recall Profile & Regulatory Data
Event ID
86520
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jan 24, 2022
Product Description
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Affected Packages Involved in this Recall
0378-3001-77Product
0378-3002-77Product
0378-3003-77Product
0378-3002-05Product
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.
