Candesartan Tablet
FDA Recall NDC 33342-116
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 (NDC 33342-116). A significant event, classified as Class III, was initiated on Mar 22, 2021 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
Failed Impurities/Degradation Specifications
Mar 22, 2021
Apr 21, 2021
8015 packs
Recall Profile & Regulatory Data
Event ID
87607
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 13, 2022
Product Description
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
Batch or Lot Expiration Information
Lot# Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
Affected Packages Involved in this Recall
33342-114-07Product
33342-114-51Product
33342-114-12Product
33342-114-10Product
33342-115-07Product
33342-115-51Product
33342-115-12Product
33342-115-10Product
33342-116-07Product
33342-116-51Product
33342-116-12Product
33342-116-10Product
33342-117-07Product
33342-117-51Product
33342-117-12Product
33342-117-10Product
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.
