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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64720

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

Open FDA event record

Event summary

Timeline bucket
August 28, 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

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

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

D-308-2013
Recall number
D-308-2013
Initiated
August 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
26,100 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: Loose crimp applied to the fliptop vial

Code information

Lot 15-065-DK, Exp 1SEP2013

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

D-309-2013
Recall number
D-309-2013
Initiated
August 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
172,350 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: Loose crimp applied to the fliptop vial.

Code information

Lot 17-100-EV and 17-399-EV

Distribution pattern

Nationwide and Puerto Rico