Exact FDA event identifier

Event 78981

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

Event summary

Timeline bucket: January 22, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Astellas Pharma US 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

Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10

D-0548-2018

Recall number: D-0548-2018
Initiated: January 22, 2018
Classification: Class II
Status: Terminated
Recalling firm: Astellas Pharma US Inc
Quantity: 63600 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength

Code information

Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20

Distribution pattern

Nationwide.