NDC 0409-3793
Ketorolac Tromethamine 15 mg per 1 mL injection, solution
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
| Hospira, Inc. | McPherson, KS, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
| Nitto Avecia Pharma Services, Inc. | Irvine, CA, United States | Tests it | No problems foundJul 25, 2025 · 8 inspections |
Recalls
- Jun 30, 2015 · Class II · Hospira Inc.
Crystallization; identified as calcium salt of Ketorolac
Lots: 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39… - Jun 30, 2015 · Class II · Hospira Inc.
Crystallization; identified as calcium salt of Ketorolac
Lots: 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015 - Jan 23, 2015 · Class II · Hospira Inc.
Crystallization
Lots: 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… - Jan 23, 2015 · Class II · Hospira Inc.
Crystallization
Lots: 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, … - Oct 6, 2014 · Class II · Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Lots: One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI - Aug 12, 2013 · Class II · Hospira, Inc.
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Lots: Lot 25048DK Exp. 01/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ketorolac: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 15 mg per 1 mL
- Approval
- ANDA ANDA074802
- On the market since
- Jun 6, 2005
- Package NDCs
0409-3793-010409-3793-190409-3793-25- Official label
- DailyMed (National Library of Medicine), updated Jul 20, 2026
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