Exact FDA event identifier

Event 69506

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

Open FDA event record

Event summary

Timeline bucket: April 17, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Wockhardt Usa 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

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .

D-0304-2015

Recall number: D-0304-2015
Initiated: April 17, 2014
Classification: Class III
Status: Terminated
Recalling firm: Wockhardt Usa Inc.
Quantity: 1,118,400 extended release tablets

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: Product was out of specification (OOS) at the 12 month long term stability testing point.

Code information

a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14

Distribution pattern

Nationwide.