Candesartan Cilexetil Tablet
FDA Recall NDC 0378-3231
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 (NDC 0378-3231). A significant event, classified as Class III, was initiated on Sep 13, 2021 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications; out of specification for Related Compound"
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
September 2021 Class III Recall: Failed Impurities/Degradation Specifications; out of specification for Related Compound
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Sep 13, 2021
Sep 22, 2021
21,094
Recall Profile & Regulatory Data
Event ID
88609
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Viatris
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Apr 28, 2022
Product Description
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Batch or Lot Expiration Information
Lot# 3107334, exp. date October 2021
Affected Packages Involved in this Recall
0378-3224-93Product
0378-3224-77Product
0378-3225-93Product
0378-3225-77Product
0378-3231-93Product
0378-3231-77Product
0378-3232-93Product
0378-3232-77Product
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.
