Exact FDA event identifier

Event 75261

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

Event summary

Timeline bucket: October 03, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: West-Ward Pharmaceuticals Corp.

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

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

D-1045-2017

Recall number: D-1045-2017
Initiated: October 03, 2016
Classification: Class II
Status: Terminated
Recalling firm: West-Ward Pharmaceuticals Corp.
Quantity: N/A

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Code information

Lot #: 71294A, Exp. 5/2017

Distribution pattern

Nationwide