FDA recall D-0620-2018

Product

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.

Reason for recall

Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

Distribution

Distributed within the United States and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-03-19

Report date

2018-03-28

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0620-2018