Pharmacovigilance Russia (EAEU)

FDA MedWatch Drug Alerts

• Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects Июль 10, 2018
  Audience: Patient, Health Professional, Pharmacy ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side...
• Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination Июнь 22, 2018
  Audience: Consumer, Health Professional ISSUE: The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and...
• Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events After Receiving Eye Injections Июнь 15, 2018
  Audience: Patient, Health Professional, Eye Care, Risk Manager ISSUE:  At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract...
• Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter Июнь 4, 2018
  Audience: Pain Management, Pharmacy, Anesthesiology, Emergency Medicine, HealthProfessional ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5...
• Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles Май 31, 2018
  Audience: Patient, Pharmacy, Health Professional ISSUE: The Fluticasone Propionate Nasal Spray 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the...
• Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules Май 29, 2018
  Audience: Patient, Pharmacy, Health Professional ISSUE: Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of Taytulla and the first four days of therapy had four...
• X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination Май 29, 2018
  [Posted 05/29/2018] AUDIENCE: Consumer ISSUE: The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised...
• Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder Май 23, 2018
  Audience: Pediatrics, Dentistry, Consumer, Health Professional, Pharmacy ISSUE: The FDA is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are...
• 95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol Май 23, 2018
  Audience: Consumer ISSUE: Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic...
• Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls Май 21, 2018
  Audience: Consumer,  Health Professional, Pharmacy ISSUE: MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray,...