Exact FDA event identifier

Event 63246

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

Event summary

Timeline bucket: September 21, 2012
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Watson Laboratories 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

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.

D-058-2013

Recall number: D-058-2013
Initiated: September 21, 2012
Classification: Class I
Status: Terminated
Recalling firm: Watson Laboratories Inc
Quantity: 4,874 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.

Code information

Lot #: 519406A, 521759A, Exp 04/14

Distribution pattern

Nationwide