CooperSurgical, Inc: Drug Recall
Recall #D-0643-2022 · 02/04/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0643-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- CooperSurgical, Inc
- Status
- Terminated
- Date Initiated
- 02/04/2022
- Location
- North Tonawanda, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,645 cartons
Reason for Recall
Non-sterility
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
Distribution Pattern
US Nationwide
Other Recalls by CooperSurgical, Inc
- Class II: Risk 06/11/2025
- Class II: Risk 06/11/2025
- Class II: Risk 06/11/2025
- Class II: Risk 11/15/2024
- Class II: Risk 11/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.