Exact FDA event identifier

Event 67095

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

Event summary

Timeline bucket: November 27, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: B. Braun Medical Inc

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

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.

D-407-2014

Recall number: D-407-2014
Initiated: November 27, 2013
Classification: Class II
Status: Terminated
Recalling firm: B. Braun Medical Inc
Quantity: 19,572 bags

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Wrong

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).

Code information

Lot No. J3D548, expiry: Oct, 2015

Distribution pattern

Nationwide in the US and Puerto Rico.