International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

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#…

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

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….

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

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…

Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication

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,…

Fecal Microbiota for Transplantation: New Safety Information – Regarding Additional Protections for Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2

[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.  …

Ivermectin Intended for Animals: Letter to Stakeholders – Do Not Use in Humans as a Treatment for COVID-19

[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…

All Ranitidine Products (Zantac): Press Release – FDA Requests Removal

[Posted 04/01/2020] ISSUE:  The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.  This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen…

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture

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 Pipeline Flex Embolization Device (Available in the US) and Pipeline Flex Embolization Device with Shield Technology (Not Available in the US) Product Codes: Pipeline Flex Embolization Device:…