Skip to main content

HSAG ESRD Alerts, Recalls, and Notices

Diverse Support Group Patient with Doctor
Top

 

  • Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

    Monday, April 22, 2019

    Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to theconsumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

    The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

    The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

    To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

    Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

    Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

    Read More
  • FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

    Wednesday, April 10, 2019

    The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

    While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

    Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

    Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

    Read More
  • The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States

    Wednesday, April 10, 2019

    The FDA is aware that some sellers are marketing pre-owned test strips or test strips not authorized for sale in the U.S. to consumers. These test strips may be sold through online marketplaces such as Amazon, eBay, and Craigslist, or directly from the seller.

    Pre-owned test strips may not be safe to use because:

    • The test strips may not be stored properly. For example, they may have been removed from their original packaging or not stored within the recommended temperature and humidity conditions. This could lead to inaccurate results.
      The expiration dates might have been changed or covered up. The use of expired test strips could lead to inaccurate results.
    • The test strips may have been tampered with and could be damaged causing them to not work properly.
    • If a user receives an inaccurate result from a test strip and uses this result as a basis for their treatment, they could take too much medication or not enough medication, potentially leading to serious patient injury, including death.
    • The test strip vials may have small amounts of blood from the previous owner on them, which can put users at risk for infection.

    Test strips that are not authorized for sale in the U.S. may not be safe to use because:

    • They could be faulty or poor quality.
    • Their ability to provide an accurate result is unknown. Certain test strips require review by the FDA prior to being authorized for sale in the U.S. to provide a reasonable assurance of safety and effectiveness of the test strips when used as intended. Test strips not authorized for sale in the U.S. have not been reviewed by the FDA, and their ability to provide an accurate result is unknown.
    • If a user receives an inaccurate result from a test strip and uses this result as a basis for their treatment, they could take too much medication or not enough medication potentially leading to serious patient injury, including death.
    • Test strips that are not authorized for sale in the U.S. are not following FDA requirements such as FDA reporting requirements. When manufacturers don’t follow these requirements, the FDA may not become aware of product malfunctions or safety issues.

    Read More
  • Influenza Season Continues with an Increase in Influenza A(H3N2) Activity

    Monday, April 1, 2019

    The Centers for Disease Control and Prevention (CDC) is issuing this health advisory to notify clinicians that influenza activity remains high in the United States, with an increasing proportion of activity due to influenza A(H3N2) viruses, continued circulation of influenza A(H1N1) viruses, and low levels of influenza B viruses. Influenza should be considered as a possible diagnosis for patients with respiratory illness while local influenza activity remains elevated. Because influenza A(H3N2) viruses may be associated with severe disease in older adults, this health advisory serves as a reminder that early empiric treatment with influenza antiviral medications is recommended for hospitalized and high-risk patients, especially those 65 years and older. Antiviral treatment should be started as soon as possible after illness onset and should not wait for laboratory confirmation.

    Read More
  • Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

    Tuesday, March 19, 2019

    Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

    The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

    The 8.4% Sodium Bicarbonate Injection, USP, is a sterile, hypertonic solution of sodium bicarbonate (NaHCO3) in water for administration by the intravenous route. It is indicated for the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, dehydration, severe diarrhea, circulatory insufficiency due to shock, cardiac arrest and severe lactic acidosis. Sodium bicarbonate is also indicated for the treatment of certain drug intoxications.

    8.4% Sodium Bicarbonate Injection, USP, NDC# 0409-6625-02, is packaged in 50 mL glass fliptop vials in a case pack of 4 x 25- 50mL. The affected lots and their expiry dates are indicated in the table below. Product was distributed Nationwide to Wholesalers/Distributors/Hospitals in the United States and Puerto Rico from August 2017 to September 2017.

    Read More
  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg

    Tuesday, March 19, 2019

    Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

    NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

    Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. 

    Read More
  • American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

    Wednesday, March 13, 2019

    American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

    Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

    Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date.

    Read More
  • FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan

    Wednesday, March 6, 2019

    Additional update to three recent MedWatch Safety Alert Recalls on Angiotensin II Receptor Blocker, including Valsartan and Losartan.

    • Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide Tablets by Torrent Pharmaceuticals Limited
      • Recall due to the detection of trace amounts of N-Methylnitrosobutyric Acid found in an active pharmaceutical ingredient (API) (03/01/19).
    • Amlodipine Valsartan Tablets and Valsartan Tablets by AurobindoPharma USA
      • Recall due to the detection of NDEA (N-Nitrosodiethylamine) Impurity (03/01/19).
    • Losartan Potassium Tablets by Camber Pharmaceuticals
      • Recall due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino Butyric Acid (NMBA) impurity found in the API (02/28/19).

    Read More
  • FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan

    Monday, March 4, 2019

    Three new MedWatch Safety Alert recall medical products have been added to the FDA Recalls webpage. 

    • Losartan Potassium Tablets by Camber Pharmaceuticals: Recall—Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid Impurity found in the Active Pharmaceutical Ingredient (API)
    • Valsartan and Amlodipine and Valsartan Tablets by Aurobindo and Acetris: Recall—Due to the Detection of N-Nitroso N-Methyl 4-amino butyric acid Impurity found in the API

    FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall.

    Read More
  • Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)

    Friday, March 1, 2019

    Recalled Product(s)
    Physio-Control, Inc. LIFEPAK15 Monitor/Defibrillator (LP15)
    Model: LIFEPAK 15 Monitor/Defibrillators with Printed Circuit Board Assembly (PCBA) part no. 3206834-011 or 3206834-012
    Serial/Lot Numbers:  See "Full List of Affected Devices"
    Manufacturing Dates: March 21, 2013, to July 18, 2016
    Distribution Dates: March 21, 2013, to July 18, 2016
    Devices Recalled in the U.S.: 8,164

    Device Use
    Physio-Control's LIFEPAK 15 Monitor/Defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient's heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient's heart rhythm so the health care provider can study the heart's electrical activity.

    The LIFEPAK 15 is designed to be used only by trained medical personnel during ground transport of a patient.

    Reason for Recall
    Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.

    Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.

    Read More