Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
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