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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70515

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

Open FDA event record

Event summary

Timeline bucket
January 23, 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 Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

D-0482-2015
Recall number
D-0482-2015
Initiated
January 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials

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

NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015; Lot number 26-151-DK, Exp. Date:1FEB2015; Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015; Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015; Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015; Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015; Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016; Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016; Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016; Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016; Lot number: 41-078-DK, Exp. Date:1MAY2016; Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016; Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016; Lot number: 46-043-DK, 46-044-DK, 46-047-DK, Exp. Date:1OCT2016 AND NOVAPLUS LABEL NDC 0409-3795-49, Lot number: 27-101-DK, Exp. Date:1MAR2015; Lot number: 35-229-DK, Exp. Date:1NOV2015; Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and Lot number: 40-534-DK, Exp. Date:1APR2016

Distribution pattern

U.S. Nationwide and International: Guam and Singapore.

drug · product 2 of 2

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

D-0483-2015
Recall number
D-0483-2015
Initiated
January 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials

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

NDC 0409-3796-01, Lot number: 26-098-DK, Exp. Date:1FEB2015; Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015; Lot number: 34-540-DK, Exp. Date:1OCT2015; Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016; Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016; Lot number: 44-076-DK, Exp. Date:1AUG2016; Lot number: 45-240-DK, Exp. Date:1SEP2016 and Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label NDC 0409-3796-49, Lot number: 26-097-DK, Exp. Date:1FEB2015.

Distribution pattern

U.S. Nationwide and International: Guam and Singapore.