CLASS II ONGOING Drug recall · Reported 22 Jul 2015 · FDA Enforcement Report
Ketorolac Tromethamine Inj., USP, 60 mg recalled by Hospira
Hospira is recalling Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL) Fill Single-dose Vials, I.V/I.M, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1242-2015
- FDA event ID
- 71681
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2015
- FDA classified
- 15 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 30 Jun 2015 | Recall initiated by company | |
| 15 Jul 2015 | Classified by FDA | +15 days |
| 22 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization; identified as calcium salt of Ketorolac
Product as listed by the FDA
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
Where it was distributed
Nationwide, Puerto Rico, Guam, Canada and Singapore
Questions about this recall
Is Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL) Fill Single-dose Vials, I.V/I.M recalled?
Yes. Hospira recalled Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL) Fill Single-dose Vials, I.V/I.M on 30 Jun 2015. The recall is Class II and its status is Ongoing. Recall number D-1242-2015.
Why was it recalled?
Crystallization; identified as calcium salt of Ketorolac
Which lots are affected?
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
Where was it sold?
Nationwide, Puerto Rico, Guam, Canada and Singapore
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ketorolac Tromethamine recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine | Aspiro Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalledKetorolac Tromethamine | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Ketorolac Tromethamine Injection, USP, 30 mg per mL recalledKetorolac Tromethamine | Fresenius Kabi USA | Particulate Matter | Nationwide |