FDA Drug recall D-304-2013
Jevantique (norethindrone acetate and ethinyl estradiol) tablets
- FDA Drug
- Class III
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class III recall of Jevantique (norethindrone acetate and ethinyl estradiol) tablets by Warner Chilcott, citing chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-304-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-15 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Warner Chilcott |
| Distribution | US |
Product
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Identifiers
| code_info | Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13 |
|---|
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-304-2013%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.