D-0643-2022 Class I Terminated
FDA drug recall D-0643-2022 was initiated by CooperSurgical, Inc on Feb 4, 2022 and is designated Class I. Reason for recall: Non-sterility The recall status is terminated (terminated Feb 6, 2023). Affected quantity: 48,645 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 23, 2022
- Initiation Date
- Feb 4, 2022
- Termination Date
- Feb 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,645 cartons
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
Distribution Pattern
US Nationwide
Code Information
Lot # 517001,Exp 1/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0643-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026