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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63884

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

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Event summary

Timeline bucket
November 21, 2012
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

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

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

D-096-2013
Recall number
D-096-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hospira, Inc.
Quantity
145,400 vials

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: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Code information

Lot #: 11-293-DK, Exp 05/01/13

Distribution pattern

Nationwide and Puerto Rico.