Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, October 13, 2021 BOSTON – A Florida man pleaded guilty today in federal court in Boston in connection with a scheme to deceive banks and credit card companies into processing more than $150 million in credit and debit card payments on behalf of merchants involved…
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
Summary Company Announcement Date: October 12, 2021 FDA Publish Date: October 12, 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 Hydrochloride Topical Solution USP 4% (40 mg/mL) Company Announcement Buena, NJ, Teligent Pharma, Inc….
Nestlé Professional Issues Allergy Alert on Undeclared Peanuts in Nature’s Heart 1.5 Ounce Products
Summary Company Announcement Date: October 07, 2021 FDA Publish Date: October 09, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: Nestlé Professional Brand Name: Brand Name(s) Nature’s Heart Product Description: Product Description Fruit and trail mix products Company Announcement Nestlé Professional, Solon, OH is recalling four Nature’s…
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
Date Issued: October 5, 2021 The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test…
Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
Date Issued: October 8, 2021 The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. The FDA is aware…
Maple Island Inc. Issues a Voluntary Recall of Three Lots of Parent’s Choice Rice Baby Cereal
Summary Company Announcement Date: October 08, 2021 FDA Publish Date: October 08, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Tested above the guidance for naturally occurring inorganic arsenic. Company Name: Maple Island Inc. Brand Name: Brand Name(s) Parent’s Choice Product Description: Product Description Rice Baby Cereal Company Announcement Maple Island…
Northeast Seafood Products Recalls Seafood Products Because of Possible Health Risk
Summary Company Announcement Date: October 08, 2021 FDA Publish Date: October 08, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential for Salmonella Company Name: Northeast Seafood Products Brand Name: Brand Name(s) Northeast Seafood Products Product Description: Product Description Raw, fresh seafood Company Announcement Northeast Seafood Products, Denver, CO, is voluntarily…
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
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: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Product Codes for CYSTO Pack PGYBK/89-5721.03 and GU TUR BASIN SET PGYBK/89-6425.07: See Recall Database…
Ophthalmologist Pleads Guilty to Using Misbranded Medication
Department of JusticeU.S. Attorney’s OfficeWestern District of North Carolina FOR IMMEDIATE RELEASETuesday, October 5, 2021 The United States Also Agreed to a $450,000 Settlement to Resolve False Claims Act Liability CHARLOTTE, N.C. – Dr. James W. Heroman, 43, formerly of Charlotte, appeared before U.S. Magistrate Judge David S. Cayer on Monday, October 4, 2021, and…
North Andover Woman Sentenced for Performing Illegal Silicone Injections
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, October 6, 2021 Defendant injected individuals with silicone oil, which can cause stroke, death or disfigurement BOSTON – A North Andover woman was sentenced today in federal court in Boston for performing illegal silicone injections in exchange for money. Gladys Araceli Ceron, 73, was sentenced…