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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64116

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 19, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ascend Therapeutics Inc

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

1 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 1

EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***

D-146-2013
Recall number
D-146-2013
Initiated
November 19, 2012
Classification
Class III
Status
Terminated
Recalling firm
Ascend Therapeutics Inc
Quantity
4, 835 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Pump head detaching from the canister unit upon removal of the overcap.

Code information

Lot Number: EHAD Exp. 07/14

Distribution pattern

Products were distributed nationwide.