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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75253

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

Open FDA event record

Event summary

Timeline bucket
September 07, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biocompatibles U.K., Ltd.

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

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

D-0001-2017
Recall number
D-0001-2017
Initiated
September 07, 2016
Classification
Class III
Status
Terminated
Recalling firm
Biocompatibles U.K., Ltd.
Quantity
3,254 administration packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

Code information

Lot # 476670,476669,476659,475250; Exp 11/16

Distribution pattern

Distributed nationwide