June 2019 FDA Recall Estradiol Vaginal Inserts by Glenmark Pharmaceuticals Inc., Usa
D-1340-2019 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on June 3, 2019 for the product Estradiol Vaginal Inserts. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1340-2019

Reason for Recall
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Initiated
06-03-2019
Reported
06-19-2019
Quantity
31,656 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83019
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-02-2022
Product Description About Product Description
Full technical description of the product.
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71

Batch or Lot Expiration Information

Lot# : 20180516, Exp 4/30/2020

Affected Packages Involved in this Recall

68462-711-71 Estradiol Vaginal Inserts
68462-711-88 Estradiol Vaginal Inserts