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., Nort

FDA recall notice · announced February 23, 2022 · Coopersurgical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: US Nationwide
Lot/code information: Lot # 517001,Exp 1/2024
Quantity: 48,645 cartons
Status: Terminated
Products in this recall event:
- 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 In (D-0643-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.