Montelukast Sodium Tablet, Chewable
FDA Recall NDC 33342-110
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 Montelukast Sodium (NDC 33342-110). A significant event, classified as Class III, was initiated on Jan 20, 2020 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product"
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 Dissolution Specifications: testing revealed low out of specification result in one lot of product
Jan 20, 2020
Feb 05, 2020
10680 units
Recall Profile & Regulatory Data
Event ID
84749
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
Apr 26, 2021
Product Description
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Batch or Lot Expiration Information
Lot# : BMD8901B, Exp. Date 02/2021
Affected Packages Involved in this Recall
33342-110-07Product
33342-110-10Product
33342-110-15Product
33342-110-12Product
33342-110-39Product
33342-110-44Product
33342-111-07Product
33342-111-10Product
33342-111-15Product
33342-111-12Product
33342-111-39Product
33342-111-44Product
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.
