Why it was recalled
Non-sterility: due to a failed sterility test
Product description
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Lot numbers, UPCs & expiration codes
508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
Where it was sold
NY and KY
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-1354-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2014
- FDA report date
- Jun 4, 2014
- Quantity
- 47890
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1354-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67809
- Address
- 425 Privet Rd
- Code information
- 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
- Postal code
- 19044-1220
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1354-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 47890
- Termination date
- Nov 14, 2014
- Reason for recall
- Non-sterility: due to a failed sterility test
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
- Distribution pattern
- NY and KY
- Recall initiation date
- Mar 21, 2014
- Initial firm notification
- Letter
- Center classification date
- May 28, 2014