Estradiol Vaginal Inserts Tablet, Film Coated
FDA Recall NDC 68462-711
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Estradiol Vaginal Inserts (NDC 68462-711). A significant event, classified as Class II, was initiated on Oct 22, 2019 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Oct 22, 2019
Nov 06, 2019
216,840 cartons
Recall Profile & Regulatory Data
Event ID
84071
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 07, 2021
Product Description
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Batch or Lot Expiration Information
Batch# Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020
Affected Packages Involved in this Recall
68462-711-71Product
68462-711-88Product
Class II Terminated
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Jun 03, 2019
Jun 19, 2019
31,656 boxes
Recall Profile & Regulatory Data
Event ID
83019
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
May 02, 2022
Product Description
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
68462-711-71Product
68462-711-88Product
Class II Terminated
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Dec 26, 2018
Jan 16, 2019
96,240 applicators
Recall Profile & Regulatory Data
Event ID
81876
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Termination Date
Oct 06, 2020
Product Description
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
68462-711-71Product
68462-711-88Product
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.
