FDA recall D-0350-2019

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 for recall

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

Distribution

Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.

Key facts

Status

Terminated

Initiation date

2018-12-26

Report date

2019-01-16

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2019