Drug product

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

D-0258-2026

October 03, 2025

Class II

Product summary

Firm: Advanced Pharmaceutical Technology, Inc.
Event: Event 97821
Status: Ongoing
Classification: Class II
Quantity: 22,843 pellets
Official record key: drug-enforcement:D-0258-2026

Official wording

Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Code information: Lot #: P-22-3, Exp 06-2027

Distribution pattern: GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece

Derived failure modes

Microbial contamination
reason.microbial_contamination · v1.0.0

microbial contamination
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility