FDA-Drug2026-01-21Class IIPROCESSING DEFECT
Advanced Pharmaceutical Technology TESTO-100 testosterone pellets recalled for potential microbial contamination
Stop using TESTO-100 testosterone pellets
Advanced Pharmaceutical Technology is recalling TESTO-100 CIII testosterone pellets (Lot P-22-3, expiration 06-2027) because they may not be sterile and could be contaminated with harmful microbes. These are prescription implant pellets used for testosterone replacement therapy. The recall affects 22,843 pellets distributed in Georgia, New York, Texas, Puerto Rico, the United Kingdom, Malta, and Greece.
- If you have received TESTO-100 pellets from Lot P-22-3, contact your doctor or pharmacist immediately.
- Do not use the pellets unless your healthcare provider confirms they are safe.
- Ask your provider about safe alternatives or next steps for your treatment.
Hazard
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Sold states
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Affected count
22,843 pellets
Manufactured in
132 S Central Ave, Elmsford, NY, United States
Products
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2026Don't want to check this manually?
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