Exact FDA event identifier

Event 77071

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

Event summary

Timeline bucket: April 20, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Akorn, 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

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

D-0697-2017

Recall number: D-0697-2017
Initiated: April 20, 2017
Classification: Class III
Status: Terminated
Recalling firm: Akorn, Inc.
Quantity: 1,292 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product is being recalled due to low pH value.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product is being recalled due to low pH value.

Code information

Kit Lot #031126; Exp 8/2018

Distribution pattern

Nationwide