Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Crystalization Company Name: Zydus Pharmaceuticals Inc. Brand Name: Brand Name(s) Zydus Pharmaceuticals Product Description: Product Description Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials Company Announcement Pennington, NJ,…
Benzedrex (propylhexedrine): Drug Safety Communication – FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious Harm
[Posted 03/25/2021] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization,…
Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 26, 2021 FDA Publish Date: March 26, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Namoo Enterprise LLC Brand Name: Brand Name(s) PremierZen Product Description: Product Description Dietary Supplement for male sexual enhancement Company Announcement Little Ferry, NJ, Namoo Enterprise LLC is…
S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 25, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil & Tadalafil Company Name: S&B Shopper LLC Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement for Male Enhancement Company Announcement S&B Shopper LLC is voluntarily recalling all lots of…
Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of Endotoxins
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 Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface Model BBP241 Lot: 13340434 Perfusion Tubing Packs built with the affected Affinity Pixie™ CVR Models: BB10H89R4, HY10J00R6, HY11B40R1…
ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries 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 ACIST Kodama Intravascular Ultrasound Catheter Lots: 00233370, 00233371, 00233372, 00233373, 00233385 Distribution Dates: November 10, 2020 to January 14, 2021 Devices Recalled in the U.S.: 490 Date…
PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles Because They Resemble Small Water Bottles
Summary Company Announcement Date: March 16, 2021 FDA Publish Date: March 17, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Because they resemble water bottles; risk of ingestion Company Name: PNHC, LLC d/b/a Heal the World Brand Name: Brand Name(s) Heal the World Product Description: Product Description Hand Sanitizer Company Announcement Raleigh, North…
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication
Date Issued: March 15, 2021 The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as three to four years after implantation in all Scandinavian Total Ankle Replacement devices (STAR Ankle). Fracture…
Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. The false positive results may be related…
Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles
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 Products Combat Medical Convenience Kits: Valkyrie LTOWB Collection and Administration Models: 80-820, NSN 6515016862423 and 80-821 NSN 6515016862401 Low Titer Type O FWB Transfusion Set and Low Titer…