Exact FDA event identifier

Event 65541

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

Event summary

Timeline bucket: March 22, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Watson Laboratories, Inc.-(Actavis) - Florida

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

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60

D-817-2013

Recall number: D-817-2013
Initiated: March 22, 2013
Classification: Class II
Status: Terminated
Recalling firm: Watson Laboratories, Inc.-(Actavis) - Florida
Quantity: 392,400 tablets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Tablet/Capsule Specifications: Broken tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets

Code information

Lot 635098A, Exp 10/14

Distribution pattern

Nationwide