Hospira has announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials. The particulate was identified as calcium-ketorolac crystals. Multiple lots are impacted by this recall; refer to the addendum for product list and lot information.
If particulates are not observed prior to administration, intramuscular (IM) or intravenous (IV) administration theoretically could result in localized inflammation, allergic reaction, granuloma formation or microembolic effects (IV only). However, there is no evidence indicating that IM or IV injection of inert particles results in harm to patients when only a small amount over a limited period of time is administered as is the case with ketorolac. Delay of therapy may occur due to particulates blocking the infusion of solution or due to observation of particulates at the point of care. However, this delay is likely to be of negligible clinical significance as this medication is administered by a health care provider and remediation is readily available.
The lots were distributed from February 2013 to December 2014 in the United States and from January 2014 to July 2014 in Singapore. Hospira has not received reports of any adverse events associated with this issue for these lots to date. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. This recall is being carried out to the medical facility/retail level. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. Hospira has notified its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-888-345-4680 between the hours of 8am to 5pm ET, Monday through Friday. Customers outside the United States should work with their local Hospira offices to return the product per the local recall notification.
For clinical inquiries, please contact Hospira using the information provided below.
| Hospira Contact | Contact Information | Areas of Support |
|---|---|---|
| Hospira Global Complaint Management | 1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com) | To report adverse events or product complaints |
| Hospira Medical Communications | 1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week) | Medical inquiries |
| Product | NDC Number | Lot* | Expiration Date |
|---|---|---|---|
| Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose | 0409-3795-01 | 25-047-DK | 1JAN2015 |
| 25-048-DK | 1JAN2015 | ||
| 26-151-DK | 1FEB2015 | ||
| 28-059-DK | 1APR2015 | ||
| 28-071-DK | 1APR2015 | ||
| 28-072-DK | 1APR2015 | ||
| 28-479-DK | 1APR2015 | ||
| 28-480-DK | 1APR2015 | ||
| 29-556-DK | 1MAY2015 | ||
| 29-557-DK | 1MAY2015 | ||
| 35-232-DK | 1NOV2015 | ||
| 35-233-DK | 1NOV2015 | ||
| 35-234-DK | 1NOV2015 | ||
| 35-501-DK | 1NOV2015 | ||
| 36-341-DK | 1DEC2015 | ||
| 36-342-DK | 1DEC2015 | ||
| 36-343-DK | 1DEC2015 | ||
| 36-353-DK | 1DEC2015 | ||
| 36-429-DK | 1DEC2015 | ||
| 36-430-DK | 1DEC2015 | ||
| 37-141-DK | 1JAN2016 | ||
| 37-142-DK | 1JAN2016 | ||
| 37-144-DK | 1JAN2016 | ||
| Product | NDC Number | Lot* | Expiration Date |
| Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose | 0409-3795-01 | 37-145-DK | 1JAN2016 |
| 37-353-DK | 1JAN2016 | ||
| 38-141-DK | 1FEB2016 | ||
| 38-143-DK | 1FEB2016 | ||
| 39-014-DK | 1MAR2016 | ||
| 39-104-DK | 1MAR2016 | ||
| 40-301-DK | 1APR2016 | ||
| 40-536-DK | 1APR2016 | ||
| 40-537-DK | 1APR2016 | ||
| 40-544-DK | 1APR2016 | ||
| 40-548-DK | 1APR2016 | ||
| 41-078-DK | 1MAY2016 | ||
| 42-207-DK | 1JUN2016 | ||
| 42-253-DK | 1JUN2016 | ||
| 45-358-DK | 1SEP2016 | ||
| 45-359-DK | 1SEP2016 | ||
| 46-043-DK | 1OCT2016 | ||
| 46-044-DK | 1OCT2016 | ||
| 46-047-DK | 1OCT2016 | ||
| Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose, NOVAPLUS® | 0409-3795-49 | 27-101-DK | 1MAR2015 |
| 35-229-DK | 1NOV2015 | ||
| 36-217-DK | 1DEC2015 | ||
| 36-218-DK | 1DEC2015 | ||
| 40-534-DK | 1APR2016 | ||
| Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose | 0409-3796-01 | 26-098-DK | 1FEB2015 |
| 29-239-DK | 1MAY2015 | ||
| 29-240-DK | 1MAY2015 | ||
| 34-540-DK | 1OCT2015 | ||
| 37-037-DK | 1JAN2016 | ||
| 37-038-DK | 1JAN2016 | ||
| 37-147-DK | 1JAN2016 | ||
| 37-148-DK | 1JAN2016 | ||
| 37-228-DK | 1JAN2016 | ||
| 37-282-DK | 1JAN2016 | ||
| 41-282-DK | 1MAY2016 | ||
| 41-284-DK | 1MAY2016 | ||
| 44-076-DK | 1AUG2016 | ||
| 45-240-DK | 1SEP2016 | ||
| 46-306-DK | 1OCT2016 | ||
| Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose, NOVAPLUS® | 0409-3796-49 | 26-097-DK | 1FEB2015 |
*Note: the lot number may be followed by additional numbers from 01 to 99
