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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67317

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hospira 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

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

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05

D-1035-2014
Recall number
D-1035-2014
Initiated
January 09, 2014
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
15258 bags

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; potential leakage from administrative port.

Code information

Lot #: 26-123-JT, Exp: 8/14

Distribution pattern

Nationwide including Puerto Rico

drug · product 2 of 2

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.

D-1036-2014
Recall number
D-1036-2014
Initiated
January 09, 2014
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
27780 bags

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; potential leakage from administrative port.

Code information

Lot #: 26-125-JT, Exp: 8/14

Distribution pattern

Nationwide including Puerto Rico