Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67259

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

Open FDA event record

Event summary

Timeline bucket
December 20, 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

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, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

D-1082-2014
Recall number
D-1082-2014
Initiated
December 20, 2013
Classification
Class II
Status
Terminated
Quantity
5987 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Code information

Lot# 605957A, Exp 09/14

Distribution pattern

Nationwide

Field note

Send feedback

We'll only use this to respond to your feedback.