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PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion ...

FDA Recall #D-0643-2022 — Class I — February 4, 2022

Recall #D-0643-2022 Date: February 4, 2022 Classification: Class I Status: Terminated

Product Description

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

Recalling Firm

CooperSurgical, Inc — North Tonawanda, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

48,645 cartons

Distribution

US Nationwide

Code Information

Lot # 517001,Exp 1/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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