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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70770

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 18, 2015
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

2 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 2

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

D-0425-2015
Recall number
D-0425-2015
Initiated
March 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
597,498 units total

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. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Code information

Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.

Distribution pattern

Nationwide

drug · product 2 of 2

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

D-0426-2015
Recall number
D-0426-2015
Initiated
March 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
48,874

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. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Code information

Lot #: C926899, Exp 7/31/2015

Distribution pattern

Nationwide