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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91379

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

Open FDA event record

Event summary

Timeline bucket
December 29, 2022
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Pfizer 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

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

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

D-0097-2023
Recall number
D-0097-2023
Initiated
December 29, 2022
Classification
Class II
Status
Completed
Recalling firm
Pfizer Inc.
Quantity
62,088 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: Bags have the potential to leak.

Code information

Lot: 5935283, Exp. 12/01/2023

Distribution pattern

Nationwide in the USA.