Amlodipine Besylate Tablet
FDA Recall NDC 68382-121
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 Amlodipine Besylate (NDC 68382-121). A significant event, classified as Class III, was initiated on Oct 01, 2014 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344."
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
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Oct 01, 2014
Dec 03, 2014
15,144 bottles
Recall Profile & Regulatory Data
Event ID
69676
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2016
Product Description
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Batch or Lot Expiration Information
Lot# : MP4344, Exp 04/2016
Affected Packages Involved in this Recall
68382-121-01Product
68382-121-05Product
68382-121-16Product
68382-121-77Product
68382-122-16Product
68382-122-01Product
68382-122-05Product
68382-122-77Product
68382-123-16Product
68382-123-01Product
68382-123-05Product
68382-123-77Product
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.
