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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77584

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

Open FDA event record

Event summary

Timeline bucket
June 19, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fagron Compounding Services LLC dba Fagron Sterile Services

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

Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405

D-0946-2017
Recall number
D-0946-2017
Initiated
June 19, 2017
Classification
Class II
Status
Terminated
Quantity
1,056 5mL 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

Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier

Code information

Lot #: C274-000000331, BUD 08/30/2017; C274-000001274, BUD 09/07/2017; C274-000001326, BUD 09/14/2017

Distribution pattern

Nationwide in the USA