Femtrace 0 — Class III drug recall D-142-2013
Terminated recall by Warner Chilcott Company LLC, reported 2013-02-06, distributed nationwide. Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
| Recall number | D-142-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Warner Chilcott Company LLC, Fajardo, PR, United States |
| Recall initiated | 2012-12-21 |
| Classified | 2013-01-31 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,155 bottles |
| Reason classes | specification failure |
Product
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Reason for recall
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
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-142-2013. 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.