Summary Company Announcement Date: December 27, 2021 FDA Publish Date: December 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Unit may not properly dispense medication. Company Name: Padagis Brand Name: Brand Name(s) Product Description: Product Description Nitroglycerin Lingual Spray Company Announcement FOR IMMEDIATE RELEASE – Allegan, Michigan – December 27, 2021 –…
Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers
December 22, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about our ongoing evaluation and monitoring of device failures associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including the Cardiosave (Hybrid and Rescue), CS300, and CS100/CS100i. The FDA recently became aware that Maquet/Datascope Cardiosave Hybrid and Rescue IABP devices may…
Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine – Letter to Clinical Laboratory Staff and Health Care Providers
December 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false reactivity, or “false-positive”, Rapid Plasma Reagin (RPR; non-treponemal) test results, when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit, can occur in some people who received a COVID-19 vaccine. Based on…
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
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 Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing Dates: December 2011 to Present Distribution Dates: March…
Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM Sold in 2019 Due to Microbial Contamination Concerns
Summary Company Announcement Date: December 10, 2021 FDA Publish Date: December 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Efficient Laboratories, Inc Brand Name: Brand Name(s) Rompe Pecho Product Description: Product Description Liquid Cold & Flu symptom relief Company Announcement FOR IMMEDIATE RELEASE – 12/09/2021 – Miami, Florida….
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency
Summary Company Announcement Date: December 07, 2021 FDA Publish Date: December 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Teligent Pharma, Inc. Product Description: Product Description Lidocaine HCl Topical Solution USP 4%, 50ml Company Announcement FOR IMMEDIATE RELEASE –07 December 2021…
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
Summary Company Announcement Date: December 04, 2021 FDA Publish Date: December 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products Company Name: Edge Pharma, LLC Brand…
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
Summary Company Announcement Date: December 03, 2021 FDA Publish Date: December 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of glass particulates Company Name: Gilead Sciences Inc. Brand Name: Brand Name(s) Product Description: Product Description Veklury® (remdesivir 100 mg for injection) Company Announcement Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD)…
Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping
Summary Company Announcement Date: December 01, 2021 FDA Publish Date: December 02, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Exposure to high temperatures may have impacted product effectiveness. Company Name: Sandoz, Inc. Brand Name: Brand Name(s) Product Description: Product Description Enoxaparin Sodium Injection Company Announcement FOR IMMEDIATE RELEASE – December 1, 2021…
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
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 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 3,241 Distribution Date: November…