Drug 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
D-0643-2022
Product summary
- Event
- Event 89462
- Status
- Terminated
- Classification
- Class I
- Quantity
- 48,645 cartons
- Official record key
drug-enforcement:D-0643-2022
Official wording
Reason: Non-sterility
Code information: Lot # 517001,Exp 1/2024
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Non-sterility