FDA recall D-0643-2022

Product

PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01

Reason for recall

Non-sterility

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2022-02-04

Report date

2022-02-23

Termination date

2023-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2022