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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87710

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

Open FDA event record

Event summary

Timeline bucket
April 12, 2021
Product types
Drug
Classifications
Class II
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

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

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

D-0335-2021
Recall number
D-0335-2021
Initiated
April 12, 2021
Classification
Class II
Status
Terminated
Recalling firm
Edge Pharma, LLC
Quantity
5850 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

Code information

Lot 02-2021-16@4 BUD 5/31/2021

Distribution pattern

Nationwide in the US