FDA’s Critical Role in Ensuring Supply of Influenza Vaccine

Image Some of the symptoms of flu and COVID-19 are similar, so it may be hard to tell the difference between these contagious respiratory illnesses without being tested. There are many benefits of flu vaccination, and preventing flu is especially important during the COVID-19 pandemic. If you think you have COVID-19, contact your health care…

Benzodiazepine Drug Class: Drug Safety Communication – Boxed Warning Updated to Improve Safe Use

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication – Boxed Warning Updated to Improve Safe Use AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction,…

Benadryl (diphenhydramine): Drug Safety Communication – Serious Problems with High Doses of the Allergy Medicine

TOPIC: Benadryl (diphenhydramine): Drug Safety Communication – Serious Problems with High Doses of the Allergy Medicine AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of…

Husband and Wife Plead Guilty to Naturalization Fraud and Conspiring to Illegally Import and Distribute Male Enhancement Products and Counterfeit Goods from China

Department of JusticeU.S. Attorney’s OfficeNorthern District of Georgia FOR IMMEDIATE RELEASEThursday, September 24, 2020 ROME, GA– Irfanali Momin and Shiba I. Momin a/k/a Saguftabanu Momin, husband and wife, have each pleaded guilty to naturalization fraud, and conspiring to illegally import misbranded drug products from China, receive misbranded drugs that had moved in interstate commerce, and to trafficking…

Wismettac Asian Foods Voluntarily Recalls Dried Fungus Due to Potential Salmonella Contamination

Summary Company Announcement Date: September 23, 2020 FDA Publish Date: September 23, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with Salmonella Company Name: Wismettac Asian Foods, Inc. Brand Name: Brand Name(s) Product Description: Product Description Dried Fungus (also known a Black Fungus or…

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Summary Company Announcement Date: September 23, 2020 FDA Publish Date: September 23, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Sun Pharmaceutical Industries Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride for Extended-Release Oral Suspension Company Announcement Sun Pharmaceutical Industries, Inc….

Registered Nurse Sentenced for Morphine Tampering

Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEMonday, September 14, 2020 BOSTON – A Haverhill nurse was sentenced in federal court in Boston today for tampering with patients’ morphine. Brianna Duffy, 32, was sentenced by U.S. District Court Judge William G. Young to 60 months in prison and three years of supervised release. In July…

Chester County Doctor Agrees to Pay Over $1.2 Million to Settle Allegations of Fraudulent Billing and Unlawful Opioid Distribution

Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASEFriday, September 18, 2020 PHILADELPHIA— United States Attorney William M. McSwain announced that Thomas J. Whalen, D.O., 65, of Berwyn, PA, has agreed to pay the United States $1,257,499.00 to resolve allegations under the False Claims Act that he submitted or caused the submission of false claims…