Exact FDA event identifier

Event 68548

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

Event summary

Timeline bucket: June 19, 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. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.

D-1412-2014

Recall number: D-1412-2014
Initiated: June 19, 2014
Classification: Class II
Status: Terminated
Recalling firm: Forest Pharmaceuticals Inc
Quantity: 92,544 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: Drug failed stage III dissolution testing.

Code information

Lot # A308879, Expiry: 09/2015

Distribution pattern

Nationwide including Puerto Rico.