Aprepitant Capsule
FDA Recall NDC 68462-583
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 Aprepitant (NDC 68462-583). A significant event, classified as Class III, was initiated on Nov 27, 2018 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack."
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
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Nov 27, 2018
Dec 26, 2018
5,016 blister packs
Recall Profile & Regulatory Data
Event ID
81639
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 12, 2019
Product Description
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
Batch or Lot Expiration Information
Lot# Lot: 17180918, EXP June 2020
Affected Packages Involved in this Recall
68462-583-11Product
68462-583-85Product
68462-583-40Product
68462-584-58Product
68462-584-40Product
68462-584-76Product
68462-585-40Product
68462-585-76Product
68462-112-33Product
3684625834Product
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.
