FDA Drug recall D-0350-2019

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, Manu…

FDA Drug
Class II
terminated
Published 2019-01-16

On 2019-01-16 the FDA classified a Class II recall of 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, Manu… by Glenmark Pharmaceuticals Usa, citing defective Delivery System: Customer complaints of malfunctioning plunger of the applicator.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0350-2019
Classification	Class II
Status	terminated
Initiated	2018-12-26
Published	2019-01-16
Last updated	2026-09-13 11:52 UTC
Company	Glenmark Pharmaceuticals Usa
Distribution	US

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

Reason

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Identifiers

ndc	68462-711-71
ndc	68462-711-88
code_info	Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/202… 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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.