Exact FDA event identifier

Event 69298

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

Event summary

Timeline bucket: September 26, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Forest Pharmaceuticals 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

Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07

D-0036-2015

Recall number: D-0036-2015
Initiated: September 26, 2014
Classification: Class II
Status: Terminated
Recalling firm: Forest Pharmaceuticals Inc
Quantity: 94,584 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specification; at the 6-month stability time point

Code information

Lot A369286, exp. date 31 Jan 2016

Distribution pattern

Nationwide including Puerto Rico.