Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

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 Lyra SARS-CoV-2 Assay (M120) Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, 032820B, 040320, 040720, 040920, 041020, 174992, 175429, 175501, 175502, 175503, 176001, 176002, 176366, 176367,…

Former West Boylston Nurse Sentenced for Tampering with Hydromorphone and Meperidine

Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, July 1, 2021 BOSTON – A former nurse was sentenced on Tuesday, June 29 in federal court in Boston for tampering with opioids intended for emergency department patients at a hospital where he worked and then attempting to conceal his crime by replacing the diverted…

Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

June 30, 2021 The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized…

Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

Summary Company Announcement Date: June 30, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Teva Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Topotecan Injection 4 mg/4 mL (1 mg/mL) Company Announcement Teva Pharmaceuticals has initiated a voluntary recall of…

Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink Containers

Summary Company Announcement Date: July 01, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaged in bottles that resemble drink containers Company Name: Ardil Commercial Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling…

Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile

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 Angiographic Guidewire Component Model Numbers: WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No: 107042 WIRE ANGIO 107044 PNS .038X145 3MMJ PTFE; Part No: 107044 WIRE ANGIO…

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

Date Issued: June 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to…

Manna Pro Products LLC Issues Limited Voluntary Recall of Flock Party Quack Snacks Sold in the United States Because of Possible Health Risk Due to Potential Salmonella Contamination

Summary Company Announcement Date: June 28, 2021 FDA Publish Date: June 29, 2021 Product Type: Animal & VeterinaryFood & Beverages Pet Food Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Manna Pro Products, LLC Brand Name: Brand Name(s) Flock Party Product Description: Product Description Duck treats Company Announcement Manna…