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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65061

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

Open FDA event record

Event summary

Timeline bucket
February 27, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp.

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

0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

D-623-2013
Recall number
D-623-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
317,280 bags

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling Wrong Barcode; It may display wrong

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

Code information

Lot: P293118; Exp Date: 10/13

Distribution pattern

Nationwide and Singapore

Field note

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