FDA recall D-1354-2014
Teva Pharmaceuticals USA · Class II · drug
Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Reason for recall
Non-sterility: due to a failed sterility test
Distribution
NY and KY
Key facts
- Status
- Terminated
- Initiation date
- 2014-03-21
- Report date
- 2014-06-04
- Termination date
- 2014-11-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Horsham, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1354-2014