Drug product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
D-1354-2014
Product summary
- Event
- Event 67809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47890
- Official record key
drug-enforcement:D-1354-2014
Official wording
Reason: Non-sterility: due to a failed sterility test
Code information: 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
Distribution pattern: NY and KY
Derived failure modes
-
Unknown
Non-sterility: due to a failed sterility test