Drug recall: Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt
Warner Chilcott Company LLC (Fajardo, PR) initiated this drug recall on 21 Dec 2012; FDA lists 2 product records under event 64014, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 16 Jun 2015. Initiation: voluntary: firm initiated. Warner Chilcott Company LLC has 2 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Warner Chilcott Company LLC, Fajardo, PR.
Reason for recall
"Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles"
Distribution
"US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-141-12013 | Femtrace 0.9 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 | 5439 bottles | Class III | Terminated | 6 Feb 2013 |
| D-142-2013 | 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 | 3155 bottles | Class III | Terminated | 6 Feb 2013 |
Context
Other enforcement events for Warner Chilcott Company LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Feb 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx o | Drug | Class III | 3 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.