FDA recall D-0531-2025

Advanced Pharmaceutical Technology, Inc. · Class II · drug

Product

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

Reason for recall

Marketed Without an Approved NDA/ANDA

Distribution

NY, NJ

Key facts

Status: Ongoing
Initiation date: 2025-05-30
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elmsford, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2025