PARAGARD T380A — Class I drug recall D-0643-2022
Terminated recall by CooperSurgical, Inc, reported 2022-02-23, distributed nationwide. Non-sterility
| Recall number | D-0643-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc, North Tonawanda, NY, United States |
| Recall initiated | 2022-02-04 |
| Classified | 2022-03-01 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2023-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 48,645 cartons |
| Reason classes | sterility |
| NDC | 51285-0204-01 |
| Lot numbers | 517001 |
| Expiration dates | 2024-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0643-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.