Exact FDA event identifier

Event 87514

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

Event summary

Timeline bucket: December 22, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Edge Pharma, 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

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

D-0307-2021

Recall number: D-0307-2021
Initiated: December 22, 2020
Classification: Class III
Status: Terminated
Recalling firm: Edge Pharma, LLC
Quantity: 60 syringes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Code information

Lot #: 10-2020-13@8, exp. date 12/03/2020

Distribution pattern

PA only