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Tags Posts tagged with "FDA"

FDA

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The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) that include a monovalent (single) component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2. These vaccines were updated to provide better protection against COVID-19 caused by circulating variants. Two vaccines are available for use in the United States: 2024–2025 Moderna COVID-19 Vaccine and 2024–2025 Pfizer-BioNTech COVID-19 Vaccine. There is no preference for one vaccine over the other when more than one vaccine is recommended for an age group

Who should get the vaccine?

Everyone ages 6 months and older should get the 2024–2025 COVID-19 vaccine. This includes people who have received a COVID-19 vaccine before and people who have had COVID-19. The COVID-19 vaccine helps protect you from severe disease, hospitalization, and death.

It is especially important to get your 2024–2025 COVID-19 vaccine if you are:

  • Ages 65 and older,
  • At high risk for severe COVID-19
  • Have never received a COVID-19 vaccine.
  • Are living in a long-term care facility
  • Are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future.
  • Want to lower your risk of getting Long COVID

People who recently had COVID-19:

  • People who recently had COVID-19 may delay getting a COVID-19 vaccine for 3 months.
  • The risk of getting COVID-19 is less likely in the weeks to months following a SARS-CoV-2 infection.

Certain factors could be reasons to get a vaccine sooner rather than later, such as:

  • Personal risk of severe COVID-19
  • Risk of COVID-19 in a family or household member or other close contact
  • local levels of COVID-19 illness

Keep in mind‎:

  • Vaccine protection decreases over time, so it is important to stay up to date with your COVID-19 vaccine.
  • Getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19.

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The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions. The use of the affected product may cause serious adverse health consequences, including:

  • Patient injuries;
  • Delay of therapy; and
  • Death due to a period of time without compressions to circulate oxygen throughout the body.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

  • RMU-2000 Chest Compression Module
    • Product Name: RMU-2000 ARM XR Chest Compression Device
    • Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
    • Serial Numbers: See full list.

What to Do

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers). On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions:

  • Identify and quarantine affected units; and
  • If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.

Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.

Reason for Recall

Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body. There has been one reported injury and one report of death.

Device Use

The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.

Contact Information

Customers in the US with questions about this recall should contact Defibtech Customer Support at 877-453-4507, 7:30 am – 6:00 pm EST.

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The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA) about a recall of Clonazepam Orally Disintegrating Tablets due to mislabeling of the carton. This medication may be used in the treatment of Lennoz-Gastaut syndrome (petit mal variant), akinetic, myoclonic seizures, and panic disorders. Endo USA, Inc. is recalling USP (C-IV) Lot Number 550147301 due to the incorrect strength being on the product. If you have this product with the matching Lot Number, stop use immediately and contact your health care provider.

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The Office of Developmental Programs (ODP) is sharing an important announcement from the U.S. Food and Drug Administration (FDA) warning individuals of the risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGM). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own. If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.

View the FDA alert here.

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The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about a recall of two cough medicine products by Robitussin. The products are Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult. Please see the specific Lot Numbers below that are involved in the recall.  If you have one of these products with the matching Lot Number, stop use immediately and contact your health care provider.

Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination

Summary
Company Announcement Date: January 24, 2024
FDA Publish Date: January 24, 2024
Product Type: Drugs
Reason for Announcement: Microbial Contamination
Company Name: Haleon
Brand Name: Robitussin
Product Description: Cough syrups

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination.

In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events, such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out. To date, Haleon has not received any reports of adverse events related to this recall.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. This recall covers only the following lots:

Product Lot Number Expiry Date
ROBITUSSIN HONEY CF MAX
DAY ADULT 4OZ		 T10810 31OCT2025
ROBITUSSIN HONEY CF MAX
DAY ADULT 8OZ		 T08730
T08731
T08732
T08733
T10808		 31MAY2025
31MAY2025
31MAY2025
31MAY2025
30SEP2025
ROBITUSSIN HONEY CF MAX
NT ADULT 8OZ		 T08740 T08742 30JUN2026
30JUN2026

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers that have purchased the product listed should stop consumption immediately. Please call our Consumer Relations team at +1-800-245-1040 (Monday through Friday 8:00 am – 6:00 pm Eastern Time) or reach out via email.

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.

  • Complete and submit the report online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

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The Office of Developmental Programs (ODP) has shared important information about eye drops from the U.S. Food and Drug Administration. Eye drops from the 26 products listed here in the FDA MedWatch warning should not be used. CVS, Rite Aid, and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby, and Velocity may still be available to purchase in stores and online and should not be purchased.

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The Office of Developmental Programs (ODP) has shared the following recall information announced by the U.S. Food and Drug Administration (FDA):

Dr. Berne’s Whole Health Products is recalling all lots of MSM DROPS 5% 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution because FDA analysis has found one lot (lot 6786) of Dr. Berne’s MSM DROPS 5% Solution to fail sterility, with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne’s is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution. These products are used as lubricating eye drops.

RISK STATEMENT: Using contaminated eye drops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.

RECOMMENDATIONS:

  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
  • Consumers/distributors/retailers that have product which is being recalled should stop using and return to the company Sun Star Organics.
  • Consumers with questions regarding this recall can contact Dr. Berne’s Whole Health Products.

Further information is available here.

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Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Please be aware, this recall is a voluntary correction, not a product removal.

Clinicians may continue to use the devices with adult patients and are instructed to not use the devices with pediatric patients.

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.

Read more here.

If you have questions about this recall, contact Draeger Service Technical Support between the hours of 8:00 am – 8:00 pm EST at 800-437-2437 (press 2 at the prompt, then 2 again).

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