Summary Company Announcement Date: April 15, 2020 FDA Publish Date: April 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Amneal Pharmaceuticals, LLC Brand Name: Brand Name(s) Gemini Laboratories Product Description: Product Description Nizatidine Oral Solution 15 mg/mL Company Announcement Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily…

The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these…

Summary Company Announcement Date: January 10, 2018 FDA Publish Date: April 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Mislabeling Company Name: International Laboratories, LLC Brand Name: Brand Name(s) International Laboratories, LLC Product Description: Product Description Clopidogrel Tablets USP, 75 mg Company Announcement International Laboratories, LLC is voluntarily recalling Lot#…

Summary Company Announcement Date: April 15, 2020 FDA Publish Date: April 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to low out of specification dissolution results Company Name: Avet Pharmaceuticals Labs Inc. Brand Name: Brand Name(s) Product Description: Product Description Tetracycline HCl Capsules, 250mg and 500mg Company Announcement Avet Pharmaceuticals Inc….

Summary Company Announcement Date: January 08, 2018 FDA Publish Date: April 15, 2020 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Presence of Glass Particles in Vial Company Name: AuroMedics Pharma LLC Brand Name: Brand Name(s) AuroMedics Pharma LLC Product Description: Product Description Ampicillin and Sulbactam for Injection USP Company Announcement East…

Date Issued: November 14, 2018 Audience: Patients who have an implanted pump that delivers medicine into the spinal fluid to treat or manage pain Caregivers of these patients Health care providers who manage the care of these patients Compounders Specialties: Anesthesiologists, General Surgeons, Neurosurgeons, Neurologists, Nurses and Nurse Practitioners, Orthopaedic Surgeons, Pain Management Specialists, Pharmacists,…

[Posted 04/09/2020] AUDIENCE: Patient, Health Professional ISSUE: Because of the potential risk of transmission of SARS-CoV-2 via Fecal Microbiota for Transplantation (FMT), FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy.  …

[Posted 04/10/2020] AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.  BACKGROUND: The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the…

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 Boston Scientific Corporation IMAGER II 5F Angiographic Catheters See lot numbers below under Full List of Affected Devices Distribution Dates: July 16, 2018 to November 26, 2019…

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 LeMaitre Over the Wire Embolectomy Catheter Catalog Numbers and Lot Numbers: See full list Manufacturing Dates : May 5, 2014 to July 17, 2019 Distribution Dates: November…