Exact FDA event identifier

Event 69724

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

Open FDA event record

Event summary

Timeline bucket: December 03, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pfizer 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.

D-0292-2015

Recall number: D-0292-2015
Initiated: December 03, 2014
Classification: Class II
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 31,569 HDPE Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

Code information

Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15

Distribution pattern

Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.