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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71939

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

Open FDA event record

Event summary

Timeline bucket
August 20, 2015
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

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

D-0418-2015
Recall number
D-0418-2015
Initiated
August 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
83,320 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: There were customer complaints of cracked and leaking glass vials.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: There were customer complaints of cracked and leaking glass vials.

Code information

Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016

Distribution pattern

Nationwide