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Alerts

June 2017

Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance

ISSUE:  Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

In the event that impacted product is administered, there is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Alvogen has not received any reports of adverse events associated with use of the product.

BACKGROUND: Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. See the MedWatch Safety alert which includes a link to the Company Announcement for list of product lot numbers affected which were distributed nationwide in the USA to wholesalers and hospitals between May 2016 and June 2017.

Posted June 19, 2017- Get Full Details


May 2017

Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations

ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

Posted May 16, 2017- Get Full Details


April 2017

Hospira Issues a Voluntary Nationwide Recall For One Lot Of 25% Dextrose Injection, USP (Infant) Due To The Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe.

In the event that the particulate is administered to a patient,it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction.

Get the full details.


CDC Recommendations for Diagnosing and Managing Shigella Strains with Possible Reduced Susceptibility to Ciprofloxacin

This Health Advisory describes the identification of emerging Shigella strains with elevated minimum inhibitory concentration values for ciprofloxacin and outlines new recommendations for clinical diagnosis, management, and reporting, as well as new recommendations for laboratories and public health officials. Current interpretive criteria provided by the Clinical and Laboratory Standards Institute (CLSI) categorize these strains as susceptible to ciprofloxacin, which is a fluoroquinolone antibiotic and a key agent in the management of Shigella infections.

However, recent data from the Centers for Disease Control and Prevention (CDC) and state and local public health partners show that these strains often have a quinolone resistance gene that may lead to clinically significant reduced susceptibility to fluoroquinolone antibiotics. Clinicians treating patients with multidrug-resistant shigellosis for whom antibiotic treatment is indicated should avoid prescribing fluoroquinolones if the ciprofloxacin MIC is 0.12 μg/mL or higher even if the laboratory report identifies the isolate as susceptible, and should work closely with their clinical microbiology laboratory and infectious disease specialists to determine appropriate antimicrobial therapy.

Shigellosis is a nationally notifiable condition, and all cases of shigellosis should be reported to local health departments.

Posted April 18, 2017- Get Full Details


March 2017

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:

  • HeartStart MRx Monitor/Defibrillator
  • Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Manufacturing dates: February 11, 2004 to November 4, 2016
  • Distribution dates: February 12, 2004 to November 4, 2016
  • Devices Recalled in the U.S.: 47,362 units nationwide

Reason for Recall

Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

Posted March 24, 2017- Get Full Details


February 2017

Chlorhexidine Gluconate: Drug Safety Communication –

Rare but Serious Allergic Reactions

 

ISSUE: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. See the FDA Drug Safety Communication for a data summary.

As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.

Posted February 2, 2017- Get Full Details


January 2017

Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

ISSUE: Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States.

If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

Posted January 25, 2017


Class 2 Device Recall - Tego Connector

The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

Posted January 18, 2017


Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

ISSUE: Physio-Control announced that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.  

The company has received 34 reports where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. The company is aware of 8 adverse events related to this issue.  

See the FDA Release: January 14, 2017


Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

 
Recalled Product:
·         Product Name: Normal Saline Flush
·         Product Description: 12 mL IV Flush Syringe with a 3 mL, 5 mL, or 10 mL fill volume
·         Product Codes: All lots of product codes: 1203, 1205, 1210 and 1210-BP
·         Manufacturing Dates: September 24, 2015 to August 1, 2016
·         Distribution Dates: February 16, 2016 to September 30, 2016
·         Devices Recalled in the U.S.: 386,175 syringes nationwide

Device Use
The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.

Reason for Recall
Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.

According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people "vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis."

The use of affected products may cause serious adverse health consequences including bloodstream bacterial infections and death.

 

Recall Initiated October 4, 2016- Get Full Details


October 2016

Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.

As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.

Posted October 4, 2016- Get Full Details


August 2016

Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.

Posted August 19, 2016- Get Full Details


May 2016

FDA Alert

Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors

B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
The recalled products include

  • Model numbers: 710200L, 710200K, 710200S, 710200U, 710500L, 710500K
  • Manufacturing dates: April 1, 2013 to July 3, 2013
  • Distribution dates: June 25, 2013 to October 7, 2015

Posted May 4, 2016- Get Full Details


April 2016

FDA Safety Alert

Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function
ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.

 

Posted April 8, 2016- Get Full Details

 

FDA Safety Alert

Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure
Including:
  • Onglyza (saxagliptin)
  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)
ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue.

 

Posted April 6, 2016- Get Full Details


March 2016

FDA Safety Alert

The FDA is recommending consumers, businesses, schools, and healthcare providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode.

Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death.

The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.

Posted March 30, 2016- Get Full Details


February 2016

Zika Virus

The World Health Organization declared the mosquito-borne Zika virus a global health threat, based on the suspicion that the virus may be to blame for thousands of birth defects in Brazil in the past year. The first travel-related Zika case was confirmed in Georgia on February 3. The CDC is one of the lead global agencies in the battle against this virus, and officials say the outbreak is far from over, with major challenges ahead.

Posted 2/4/2016 - Get Full Details


January 2016

CDC Health Advisory

The Centers for Disease Control and Prevention (CDC) has received an increased number of reports of newly acquired hepatitis C virus (HCV) infection among patients undergoing hemodialysis. Infection control lapses in dialysis care could expose patients to HCV. Any case of new HCV infection in a patient undergoing hemodialysis should prompt immediate action.

CDC is urging dialysis providers and facilities to:
1) Assess current infection control practices and environmental cleaning and disinfection practices within the facility to ensure adherence to infection control standards;
2) Address any gaps identified by the assessments;
3) Screen patients for HCV, following CDC guidelines, to detect infections, determine treatment potential, and halt secondary transmission; and
4) Promptly report all acute HCV infections to the state or local health department.

Posted 1/27/2016 - Get Full Details


December 2015

Baxter International Inc.

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter to date.

Posted 12/18/2015 - Get Full Details


October 2015

FDA Safety Alert

The Federal Drug Administration (FDA) is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate's potential to bind to other medications administered by mouth - drug interactions that could affect how well the other medications work..

CDC Posted 10/26/2015 - Get Full Details


September 2015

CDC Health Advisory

The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.

CDC Posted 9/11/2015 - Get Full Details


July 2015

Baxter International Inc.

The FDA has issued a Safety Announcement regarding a Voluntarily Nationwide Recall of one lot of intravenous (IV) solution to the hospital/user level due to the
potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.

FDA Posted 07/30/2015

Baxter International Inc.

The FDA has issued a Safety Announcement regarding a Voluntarily Nationwide Recall of two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.

FDA Posted 07/17/2015

FDA Safety Recall

The FDA has issued an Enforcement Report regarding NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis) due to bacterial contamination. This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

FDA Posted 07/16/2015


June 2015

CDC Health Advisory

The Centers for Disease Control and Prevention (CDC) continues to work with the World Health Organization (WHO) and other partners to closely monitor Middle East Respiratory Syndrome Coronavirus (MERS-CoV) globally, including the cases of MERS-CoV infection recently reported by China and the Republic of Korea, to better understand the risks to public health. The purpose of this HAN Advisory is to provide updated guidance to state health departments and healthcare providers in the evaluation of patients for MERS-CoV infection, which have been revised in light of the current situation in the Republic of Korea. Healthcare providers and public health officials should maintain awareness of the need to consider MERS-CoV infection in ill persons who have recently traveled from countries in or near the Arabian Peninsula or in the Republic of Korea as outlined in the guidance below. Please disseminate this information to healthcare providers, especially infectious diseases specialists, intensive care physicians, internists, infection preventionists, and to emergency departments and microbiology laboratories.

CDC Posted 06/11/2015 - Get Full Details


April 2015

Baxter International Inc.

The FDA has issued a Safety Announcement regarding a Voluntarily Nationwide Recall of select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition.

FDA Posted 04/09/2015


March 2015

FDA Drug Safety Communication

The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). 

FDA Posted 03/30/2015

Hospira, Inc.

The FDA has issued a Safety Announcement regarding a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination.

FDA Posted 03/11/2015


October 2014

Ebola Epidemic

More information on the Ebola Virus is coming out. View the latest information.


September 2014

Hospira, Inc.

The FDA has issued a Safety Announcement regarding a Voluntarily Nationwide Recall of One Lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9% Sodium Chloride Injection, 500 mL, Due to Particulate Matter
FDA Posted 09/11/2014


August 2014

Baxter International, Inc.

The FDA has issued a Safety Announcement regarding a Voluntarily Initiated U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
FDA Posted 8/13/2014.


July 2014

Baxter International, Inc.

The FDA has issued a Safety Announcement regarding a Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter.
FDA Posted 7/14/2014.


June 2014

Bristol-Myers Squibb

The FDA has issued a Safety Announcement regarding a Voluntary Nationwide Recall of COUMADIN® (Warfarin Sodium) for Injection Due to Presence of Particulate Matter.
FDA Posted 6/30/2014.

NxStage Medical, Inc.

The FDA has issued a Safety Announcement regarding recall of NxStage SAK Dialysate Concentrates that contain aluminum levels which exceed internal product specification.
FDA Posted 6/24/2014.

 


May 2014

Fresenius Medical Care North America

The FDA has issued a Safety Announcement regarding a Voluntary Nationwide and Canada Recall of NaturaLyte® Liquid Bicarbonate Concentrate Due to Potential Health Risk.
FDA posted 5/21/2014.

NxStage Medical, Inc.

Update on voluntary recall regarding SAK Dialysate Concentrate issued May 15, 2014.
Posted 5/19/2014.

Middle East Respiratory Coronavirus (Mers-CoV)

The CDC has issued a Health Advisory regarding the first case of MERS-CoV infection in the United States.
CDC posted 5/3/2014.

Baxter Healthcare Corporation

The FDA has issued a Safety Announcement regarding a recall of Sigma Spectrum Infusion Pumps with Master Drug Library due to system error that may interrupt or delay therapy.
FDA posted 5/2/2014.