Exact FDA event identifier

Event 67688

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

Event summary

Timeline bucket: February 10, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Pinnacle Biologics 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

Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75

D-1157-2014

Recall number: D-1157-2014
Initiated: February 10, 2014
Classification: Class III
Status: Terminated
Recalling firm: Pinnacle Biologics Inc
Quantity: 261 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Stability Data Does Not Support Expiry

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.

Code information

Lot Number: 0M396; Expiry: Nov 2014

Distribution pattern

US: Nationwide and Taiwan