Methylergonovine Maleate Tablet
FDA Recall NDC 69238-1605
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 Methylergonovine Maleate (NDC 69238-1605). A significant event, classified as Class II, was initiated on Mar 25, 2024 by Amneal Pharmaceuticals Ny Llc. The reported reason for this action was: "Failed Dissolution Specifications"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Failed Dissolution Specifications
Mar 25, 2024
May 08, 2024
2784 bottles
Recall Profile & Regulatory Data
Event ID
94286
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Batch or Lot Expiration Information
Lot# : BJ01922A, exp. date 03/2024
Affected Packages Involved in this Recall
69238-1605-2Product
69238-1605-8Product
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.
