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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Hospira Issues a Voluntary Global Recall of Multiple Lots of Ketorolac Tromethamine Injection Due to Potential Particulate in Glass Vials

Contact:
Consumer:
1-888-345-4680

Media:
224-212-2357

FOR IMMEDIATE RELEASE — February 10, 2015 — LAKE FOREST, Ill. — Hospira, Inc., (NYSE: HSP) 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 ContactContact InformationAreas of Support
Hospira Global Complaint Management1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com)To report adverse events
or product complaints
Hospira Medical Communications1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week)Medical inquiries

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.

ProductNDC NumberLot*Expiration Date
Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose0409-3795-0125-047-DK1JAN2015
  25-048-DK1JAN2015
  26-151-DK1FEB2015
  28-059-DK1APR2015
  28-071-DK1APR2015
  28-072-DK1APR2015
  28-479-DK1APR2015
  28-480-DK1APR2015
  29-556-DK1MAY2015
  29-557-DK1MAY2015
  35-232-DK1NOV2015
  35-233-DK1NOV2015
  35-234-DK1NOV2015
  35-501-DK1NOV2015
  36-341-DK1DEC2015
  36-342-DK1DEC2015
  36-343-DK1DEC2015
  36-353-DK1DEC2015
  36-429-DK1DEC2015
  36-430-DK1DEC2015
  37-141-DK1JAN2016
  37-142-DK1JAN2016
  37-144-DK1JAN2016
ProductNDC NumberLot*Expiration Date
Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose0409-3795-0137-145-DK1JAN2016
  37-353-DK1JAN2016
  38-141-DK1FEB2016
  38-143-DK1FEB2016
  39-014-DK1MAR2016
  39-104-DK1MAR2016
  40-301-DK1APR2016
  40-536-DK1APR2016
  40-537-DK1APR2016
  40-544-DK1APR2016
  40-548-DK1APR2016
  41-078-DK1MAY2016
  42-207-DK1JUN2016
  42-253-DK1JUN2016
  45-358-DK1SEP2016
  45-359-DK1SEP2016
  46-043-DK1OCT2016
  46-044-DK1OCT2016
  46-047-DK1OCT2016
Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose, NOVAPLUS®0409-3795-4927-101-DK1MAR2015
  35-229-DK1NOV2015
  36-217-DK1DEC2015
  36-218-DK1DEC2015
  40-534-DK1APR2016
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose0409-3796-0126-098-DK1FEB2015
  29-239-DK1MAY2015
  29-240-DK1MAY2015
  34-540-DK1OCT2015
  37-037-DK1JAN2016
  37-038-DK1JAN2016
  37-147-DK1JAN2016
  37-148-DK1JAN2016
  37-228-DK1JAN2016
  37-282-DK1JAN2016
  41-282-DK1MAY2016
  41-284-DK1MAY2016
  44-076-DK1AUG2016
  45-240-DK1SEP2016
  46-306-DK1OCT2016
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose, NOVAPLUS®0409-3796-4926-097-DK1FEB2015

*Note: the lot number may be followed by additional numbers from 01 to 99

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Page Last Updated: 02/17/2015
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