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Houston RX Recalls 64 Tirzepatide Niacinamide Vials for Sterility Issues

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Story summary
  • Houston RX LLC recalled 64 vials of tirzepatide-niacinamide after FDA inspection found sterility issues.
  • The FDA classified the recall as Class II, indicating temporary or reversible health risks.
  • Inspectors documented 14 violations, such as exposed skin, reversed cleanroom pressure, and microbial growth in ISO 5 hood.
  • Certificates were marked for research use only while niacinamide met dietary-supplement standards.
  • Patients should keep the vials, report issues to FDA MedWatch, and consult prescribers.