Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot # 517001,Exp 1/2024
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0643-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 4, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 48,645 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CooperSurgical, Inc
Original FDA data
Every field from FDA enforcement report D-0643-2022, exactly as published.
Show all FDA fields
- City
- North Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89462
- Address
- 825 Wurlitzer Dr
- Code information
- Lot # 517001,Exp 1/2024
- Postal code
- 14120-3041
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0643-2022
- Classification
- Class I
- Recalling firm
- CooperSurgical, Inc
- Product quantity
- 48,645 cartons
- Termination date
- Feb 6, 2023
- Reason for recall
- Non-sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Feb 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2022