Exact FDA event identifier

Event 61725

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

Event summary

Timeline bucket: April 24, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals 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

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

D-128-2013

Recall number: D-128-2013
Initiated: April 24, 2012
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 13,232 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Code information

Lot number 6A007046V, exp 07/12

Distribution pattern

Nationwide