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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71002

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

Open FDA event record

Event summary

Timeline bucket
April 13, 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

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

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49

D-0972-2015
Recall number
D-0972-2015
Initiated
April 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization

Code information

Lots 35-231-DK, 35-235-DK, 35-507-DK Exp. Date 1NOV2015; Lot 36-136-DK Exp. Date 1DEC2015; Lot 37-146-DK Exp. Date 1JAN2016; Lot 38-138-DK Exp. Date 1FEB2016; Lots 39-103-DK, 39-255-DK Exp. Date 1MAR2016; Lots 40-539-DK, 40-549-DK, Exp. Date 1APR2016; Lot 41-079-DK Exp. Date 1MAY2016; Lots 42-252-DK, 42-254-DK Exp. Date 1JUN2016; Lots 43-262-DK, 43-263-DK Exp. Date 1JUL2016; Lots 45-031-DK, 45-032-DK, 45-033-DK Exp. Date 1SEP2016; Lot 46-001-DK Exp. 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 35-230-DK Exp. Date 1NOV2015; Lot 40-535-DK Exp. Date 1APR2016 - Note: The lot number may be followed by additional numbers from 01 to 99

Distribution pattern

Nationwide, Puerto Rico and Guam.

drug · product 2 of 2

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49

D-0973-2015
Recall number
D-0973-2015
Initiated
April 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization

Code information

Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016; Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016; Lots 44-357-DK, 44-358-DK Exp. Date 1AUG2016; Lot 46-308-DK Exp. Date 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 38-137-DK Exp. Date 1FEB2016 - Note: The lot number may be followed by additional numbers from 01 to 99

Distribution pattern

Nationwide, Puerto Rico and Guam.