FDA/SUPPLIER CLASS OF RECALL:   Not Yet Classified

LEVEL OF NOTIFICATION:                  Consumer

SUPPLIER:                                               Trividia

Event Description:

Trividia is issuing this Medical Device Correction for the above items, including the Part # and Revision due to a labeling correction that impacts the Owner’s Brooklets/System Instructions for Use included with the meter at Purchase and the online labeling and help guides at www.trividiahealth.com. The meter, test strips, and control solution are not impacted. The Products may continue to be used and sold. This correction does not require removal of the products from where they are used or sold. The correction involves the E-5 Error Code in the “Messages” section of the owner’s Booklets/System Instructions for use. The system displays an E-5 error code for a very high blood glucose event (>600mg/dl) or when there is a test strip error. Trividia is updating the E-5 error code actions to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. This Medical device correction is to the Consumer level. Affected product started shipping August 1, 2014.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

LEVEL OF NOTIFICATION:                 Consumer

SUPPLIER:                                              Abbott - # 45290

Event Description:

Abbott is issuing an Urgent Medical Device Correction for the above items/lots due to incorrect low glucose readings.  This notification is to the Consumer level. Affected product started shipping April 6, 2025.

 Consumer Information:

To determine if your current sensor or any unused sensor(s) are potentially affected, please visit www.FreeStyleCheck.com and select “CONFIRM SENSOR SERIAL NUMBER.” You will need to locate your sensor serial number to determine if your sensor is potentially affected.

If you are currently wearing or have a FreeStyle Libre 3 / FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.com or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s).

You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com. Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost.

September 19th, 2025 - 

SUPPLIER:                                              Dr. Reddy’s - 19991

Event Description:

Dr. Reddy’s is voluntarily withdrawing the above items/lots due to the Out of Trend result observed during the 18-month stability review of related substance data. This withdrawal is to the Consumer level. Affected product started shipping December 15, 2023.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

June 4th, 2025 -

LEVEL OF NOTIFICATION:                 Consumer

SUPPLIER:                                              Amneal - # 12853

Event Description:

Amneal is voluntarily recalling the above items/lots due to tablets that may exhibit black spots due to microbial contamination. This recall is to the Consumer level. Affected product started shipping December 4, 2024.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

May 28th, 2025 -

LEVEL OF NOTIFICATION:                 Consumer

SUPPLIER:                                              Teva- # 26108

Event Description:

Teva is voluntarily recalling the above item/lot due to a single Torsemide Tablet (20mg) was discovered in each of three sealed bottles of Metoclopramide tablets. This recall is to the Consumer level. Affected product started shipping December 16, 2024.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

May 16th, 2025 - 

URGENT: Medical Device Correction

Dexcom G6 Receive - MT27408-1, Dexcom G7 Receive - MT26403-0

Description of the Problem:

Users of the Dexcom G6 or G7 Receiver have reported an issue in which the receiver may not provide audio output to alerts/alarms as expected.

April 30th, 2025 - 

FDA/SUPPLIER CLASS OF RECALL:   Not Yet Classified

LEVEL OF NOTIFICATION:                 Consumer

SUPPLIER:                                              AVKARE - # 04522, 04582

Event Description:

AVKARE is voluntarily recalling the above items/lots due to manufacturing cGMP deviations identified during an audit by the FDA. This recall is to the Consumer level. Affected product started shipping May 26, 2023.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

March 14th, 2025 - 

LEVEL OF NOTIFICATION: Consumer

SUPPLIER: Exela - # 15287

Event Description:

Exela is voluntarily recalling the above item/lots due to the complaints that some vials had an insufficient crimp on the cap and stopper which may expose the rug product to the environment and could potentially impact the sterility and purity of the product. This recall is to the Consumer level. Affected product started shipping February 5, 2025.

Consumer Information:

Patients should contact their doctor or health care provider for medical-related questions.

February 14th, 2025 - 

FDA/SUPPLIER CLASS OF RECALL:   Class II

LEVEL OF NOTIFICATION:                 Consumer

SUPPLIER:                                              BRP - # 50703,7947

Event Description:

BRP is voluntarily recalling the above items/lots due to Out of Specification (OOS) results observed in dissolution test for Morphine Sulfate Extended-Release Tablets, 100 mg Batch AD16615, during analysis at 12 month long term stability station (25*C, 60%RH).  This recall is to the Consumer level. Affected product started shipping June 7, 2024.

Consumer Information:

Please contact your healthcare provider for any medical related questions.