Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64014

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 21, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Warner Chilcott Company LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-141-12013
Recall number
D-141-12013
Initiated
December 21, 2012
Classification
Class III
Status
Terminated
Quantity
5439 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurity/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Code information

0.9 mg: 512348A

Distribution pattern

US Nationwide

drug · product 2 of 2

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

D-142-2013
Recall number
D-142-2013
Initiated
December 21, 2012
Classification
Class III
Status
Terminated
Quantity
3155 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurity/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Code information

0.45 mg: 505969A

Distribution pattern

US Nationwide