Exact FDA event identifier

Event 70155

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

Open FDA event record

Event summary

Timeline bucket: January 06, 2015
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Wallcur Incorporated

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

Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.

D-0434-2015

Recall number: D-0434-2015
Initiated: January 06, 2015
Classification: Class I
Status: Terminated
Recalling firm: Wallcur Incorporated
Quantity: 18,657 Bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

Code information

No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.

Distribution pattern

United States including Puerto Rico; and Canada