March 2024 FDA Recall Methylergonovine Maleate by Amneal Pharmaceuticals Of New York, Llc
D-0477-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on March 25, 2024 for the product Methylergonovine Maleate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0477-2024
Failed Dissolution Specifications
03-25-2024
05-08-2024
2784 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
