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Toradol FDA Alerts

The FDA Alert(s) below may be specifically about Toradol or relate to a group or class of drugs which include Toradol (ketorolac).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for ketorolac

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

May 1, 2019

Audience: Consumer, Health Professional, Pharmacy

May 1, 2019 -- Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

Ketorolac Tromethamine Injection, USP, is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.

The product is supplied in 2 ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers and distributors nationwide from January – March 2019.

Product Lot Number Expiration Date NDC Number Distribution Dates
Ketorolac Tromethamine Injection, USP, 60mg per 2mL (30mg per 1mL) M813513 Feb-2020 25021-701-02 January – March 2019

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product.  Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Customers or consumers with any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F, 8am-7pm CST.  Healthcare workers who have medical questions about Ketorolac Tromethamine Injection, USP, may contact Medical Affairs (866-625-1618, Option 3) M-F, 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

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.

Source: FDA

Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

Jul 9, 2015

Audience: Health Professional, Consumer

[Posted 07/09/2015]

ISSUE:  FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products.

Prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.

BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

RECOMMENDATION: Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/09/2015 - Drug Safety Communication - FDA]

[07/09/2015 - Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - FDA]

Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials

Feb 11, 2015

Audience: Pharmacy, Case Manager

[Posted 02/11/2015]

ISSUE: Hospira 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.

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). Delay of therapy may occur due to particulates blocking the infusion of solution or due to observation of particulates at the point of care. Multiple lots are impacted by this recall. See the press release for affected lot numbers.

BACKGROUND: 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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[02/10/2015 - Press Release - Hospira]
 

Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

Oct 6, 2014

Audience: Pharmacy, Risk Manager, Nursing

ISSUE: Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

BACKGROUND: Ketorolac Tromethamine Injection, USP, 30mg/mL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial.

The lot numbers being recalled  - MP5021, MP5024 and MP5025 - were distributed to hospitals, wholesalers and distributors nationwide from September 17, 2014 through October 1, 2014.

RECOMMENDATION: Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.  Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Ketorolac Tromethamine Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[10/03/2014 - Press Release -  Sagent Pharmaceuticals Inc]

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Nov 3, 2009

Audience: Hospital risk managers, surgical center staff, pharmacists

[UPDATED 11/03/2009] Recall expanded to include all lots of product.

[Posted 10/21/2009] American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1mL Single Dose Vial] and  NDC# 0517-0902-25 [30 mg/mL 2mL Single Dose Vial (60 mg/2mL)]. There is a potential for particulate matter in conjunction with crystallization that may be present in the product, which may result in adverse events such as  obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

This recall does not include other concentrations of American Regent Ketorolac Tromethamine Injection. The product was distributed to wholesalers and distributors nationwide. Hospitals, surgi-centers, clinics and other healthcare facilities should not use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return. 

[10/21/2009 - Press Release - American Regent]

[11/03/2009 - Press Release - American Regent]

    

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Oct 21, 2009

Audience: Hospital risk managers, surgical center staff, pharmacists

American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1mL Single Dose Vial] and  NDC# 0517-0902-25 [30 mg/mL 2mL Single Dose Vial (60 mg/2mL)]. There is a potential for particulate matter in conjunction with crystallization that may be present in the product, which may result in adverse events such as  obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

This recall does not include other concentrations of American Regent Ketorolac Tromethamine Injection. The product was distributed to wholesalers and distributors nationwide. Hospitals, surgi-centers, clinics and other healthcare facilities should not use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return. 

[10/21/2009 - Press Release - American Regent]

    

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Jun 15, 2005

Audience: Healthcare professionals and consumers

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

[April 07, 2005 - Public Health Advisory - FDA]
[April 07, 2005 - Drug Information Page - FDA]
[April 07, 2005 - Questions and Answers - FDA]

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Apr 7, 2005

Audience: Healthcare professionals and consumers

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

[April 07, 2005 - Public Health Advisory - FDA]
[April 07, 2005 - Drug Information Page - FDA]
[April 07, 2005 - Questions and Answers - FDA]

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