Exact FDA event identifier

Event 89462

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

Event summary

Timeline bucket: February 04, 2022
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: CooperSurgical, 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

PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01

D-0643-2022

Recall number: D-0643-2022
Initiated: February 04, 2022
Classification: Class I
Status: Terminated
Recalling firm: CooperSurgical, Inc
Quantity: 48,645 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-sterility

Code information

Lot # 517001,Exp 1/2024

Distribution pattern

US Nationwide