FDA Drug recall D-142-2013
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031…
- FDA Drug
- Class III
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class III recall of Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031… by Warner Chilcott, citing failed Impurity/Degradation Specifications due to moisture ingress in individual bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-142-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-21 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Warner Chilcott |
| Distribution | US |
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
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Identifiers
| code_info | 0.45 mg: 505969A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-142-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.