Exact FDA event identifier

Event 74720

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

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Event summary

Timeline bucket: June 29, 2016
Product types: Drug
Classifications: Class III
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

D-0169-2017

Recall number: D-0169-2017
Initiated: June 29, 2016
Classification: Class III
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 287,200 2 mL ampules

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

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Reason for recall

Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Code information

Lot # 34-547-DK, 34-548-DK, Exp. 10/16, Lot # 39-372-DK, Exp. 03/17 Lot Number may be followed by numbers from 01 to 99

Distribution pattern

US and Puerto Rico