FDA MedWatch News

• IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance
  Source: FDA Published on 2021-09-21
• Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device
  Source: FDA Published on 2021-09-20
• Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers
  Source: FDA Published on 2021-09-17
• Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
  Source: FDA Published on 2021-09-16
• Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set
  Source: FDA Published on 2021-09-15
• Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
  Source: FDA Published on 2021-09-15
• Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers
  Source: FDA Published on 2021-09-15
• Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
  Source: FDA Published on 2021-09-13
• All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
  Source: FDA Published on 2021-09-10
• Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
  Source: FDA Published on 2021-09-08
• ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
  Source: FDA Published on 2021-09-07
• Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
  Source: FDA Published on 2021-09-02
• Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
  Source: FDA Published on 2021-09-01
• Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
  Source: FDA Published on 2021-08-30
• Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
  Source: FDA Published on 2021-08-26