Exact FDA event identifier

Event 67809

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

Event summary

Timeline bucket: March 21, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA

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

ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY

D-1354-2014

Recall number: D-1354-2014
Initiated: March 21, 2014
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 47890

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-sterility: due to a failed sterility test

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-sterility: due to a failed sterility test

Code information

508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units

Distribution pattern

NY and KY