ParaGard T 380A — Class II drug recall D-1354-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-06-04, distributed in KY, NY. Non-sterility: due to a failed sterility test
| Recall number | D-1354-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-03-21 |
| Classified | 2014-05-28 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2014-11-14 |
| Distributed | KY, NY |
| Quantity | 47,890 |
| Reason classes | sterility |
| NDC | 51285-0204-01, 51285-0204-02 |
| Expiration dates | 2015-04 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1354-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.