FDA recall D-0156-2020

Product

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.

Reason for recall

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-10-22

Report date

2019-11-06

Termination date

2021-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0156-2020