July 2019 FDA Recall Drug by Amneal Pharmaceuticals, Inc.
D-1516-2019 - Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

This Class III drug recall was voluntarily initiated by Amneal Pharmaceuticals, Inc. on July 18, 2019 for the product Drug. The FDA reported the reason for recall as presence of foreign tablet/capsule; one promethazine tablet was found in a bottle of methylergonovine maleate tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1516-2019

Reason for Recall
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Initiated
07-18-2019
Reported
07-31-2019
Quantity
a) 2,256 bottles; b) 240 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83206
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to three major distributors who may have further distributed the product nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2020
Product Description About Product Description
Full technical description of the product.
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Batch or Lot Expiration Information

Lot# a)
Lot# BA10619A, b)
Lot# BA10619B, exp. date 07/2020