Exact FDA event identifier

Event 76484

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

Event summary

Timeline bucket: February 08, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Amerisource Health Services

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

CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25

D-0490-2017

Recall number: D-0490-2017
Initiated: February 08, 2017
Classification: Class II
Status: Terminated
Recalling firm: Amerisource Health Services
Quantity: 454 cartons

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 Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities

Code information

Lot 154527, exp 4/30/2017

Distribution pattern

Nationwide