Exact FDA event identifier

Event 79457

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

Event summary

Timeline bucket: March 05, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Pine Pharmaceuticals, LLC

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

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01

D-0607-2018

Recall number: D-0607-2018
Initiated: March 05, 2018
Classification: Class III
Status: Terminated
Recalling firm: Pine Pharmaceuticals, LLC
Quantity: 136 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.

Code information

Lot#: 18098@1, Exp. 7/16/2018

Distribution pattern

NY only