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 Cook Medical Fixed Core Wire Guide Affected Models: o Model TSCF-35-260-3 Lots: Manufacturing Dates: August 24, 2020 Distribution Dates: September 09, 2020 Devices Recalled in the U.S.:…
Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: November 09, 2020 FDA Publish Date: November 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with Burkholderia lata Company Name: Lohxa, LLC Brand Name: Brand Name(s) Product Description: Product Description Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free Company Announcement Lohxa, LLC is voluntarily recalling…
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use
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 Trevo XP ProVue Retriever Catalog Numbers and Lot Numbers: Full List of Affected Devices Manufacturing Dates: July 22, 2019 to September 9, 2019 Distribution Dates: September 18,…
Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues
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 Rashkind Balloon Septostomy Catheter Lot Numbers: See the Recall database entries below for lot numbers Product Numbers: 008764, 007160, and 007161 Distribution Dates: May 28, 2018 to…
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 500 mg Company Announcement Nostrum Laboratories, Inc….
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2…
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Kansas City, Missouri,…
Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)
Summary Company Announcement Date: October 28, 2020 FDA Publish Date: October 29, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Deviations from the specified cleaning methods may impair infusion pump Company Name: Baxter International Inc. Brand Name: Brand Name(s) Sigma Spectrum Product Description: Product Description Infusion Pumps Company Announcement Baxter International Inc….
Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: October 27, 2020 FDA Publish Date: October 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: Brand Name(s) Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Company Announcement Sunstar Americas, Inc….
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication – Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. For prescription NSAIDs, FDA is requiring changes to…