Exact FDA event identifier

Event 68860

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

Event summary

Timeline bucket: July 11, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Sandoz 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

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

D-1445-2014

Recall number: D-1445-2014
Initiated: July 11, 2014
Classification: Class III
Status: Terminated
Recalling firm: Sandoz Inc
Quantity: 781,000 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 found to be out of specification (OOS) during stability testing.

Code information

Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16

Distribution pattern

Nationwide