FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections

On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.

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FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients

The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.

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FDA Alert: Class 1 Recall of Unauthorized Covid-19 Tests

This is a reprint of an FDA Alert. SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious…

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