FDA 483 - Matrixx Initiatives Inc - October 19, 2009

The FDA Form 483 document identifies a critical deficiency regarding the reporting of serious adverse events for non-prescription drugs used in the United States. The firm failed to report multiple serious adverse events to the Secretary via the MedWatch Reporting system, as required.

Specific examples of unreported serious adverse events include: - A 6-year-old male experiencing loss of taste and smell after using CLD/Nasal Gel Spray (NDC/DIN 62750-003-10), requiring an ENT referral and antibiotic prescription (Avelox). - A 6-year-old female developing full-body hives after using RPC/RapidMelts with Vitamin C (NDC/DIN 62750-008-28), necessitating an ER visit and prednisone treatment. - A 6-year-old female experiencing tachycardia (140 bpm), abdominal pain, chest pain, and flushing after using MSN/Multisymptom Nighttime (NDC/DIN 62750-023-10), leading to an ER visit and multiple tests. - A 6-year-old male experiencing dizziness, feeling faint, and rapid heart rate after using RPC/RapidMelts with Vitamin C (NDC/DIN 62750-008-28), requiring ambulance intervention. - A 6-year-old female experiencing heart palpitations for four days after