# FDA recall D-0643-2022

> **CooperSurgical, Inc** · Class I · drug recall initiated 2022-02-04.

## 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

- **Recall number:** D-0643-2022
- **Recalling firm:** CooperSurgical, Inc
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0643-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0643-2022. Source: US FDA. Licensed CC0.

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