December 2018 FDA Recall Estradiol Vaginal Inserts by Glenmark Pharmaceuticals Inc., Usa
D-0350-2019 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on December 26, 2018 for the product Estradiol Vaginal Inserts. The FDA reported the reason for recall as defective delivery system. The product was distributed in Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product. and the recall is currently terminated.

Recall Number: D-0350-2019

Reason for Recall
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Initiated
12-26-2018
Reported
01-16-2019
Quantity
96,240 applicators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81876
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.
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ

Batch or Lot Expiration Information

Batch# Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/2020, 20180427, exp. date 02/29/2020; b) 20180338, exp. date 12/31/2019, 20180386, exp. date 01/31/2020

Affected Packages Involved in this Recall

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