CLASS II Drug recall · Reported 6 May 2015 · FDA Enforcement Report
Ketorolac Tromethamine Inj recalled by Hospira
Hospira is recalling Ketorolac Tromethamine Inj, distributed nationwide in the US. The recall was initiated on 13 Apr 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-0972-2015
- FDA event ID
- 71002
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2015
- FDA classified
- 28 Apr 2015
- Reported
- 6 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 13 Apr 2015 | Recall initiated by company | |
| 28 Apr 2015 | Classified by FDA | +15 days |
| 6 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization
Product as listed by the FDA
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
Where it was distributed
Nationwide, Puerto Rico and Guam.
Questions about this recall
Why was it recalled?
Crystallization
Which lots are affected?
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
Where was it sold?
Nationwide, Puerto Rico and Guam.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71002| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ketorolac Tromethamine Inj recalled by Hospira | Hospira | Other | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |