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Recall Observatory FDA recall evidence

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

D-0531-2025

May 30, 2025

Class II

Product summary

Firm
Advanced Pharmaceutical Technology, Inc.
Event
Event 96981
Status
Ongoing
Classification
Class II
Quantity
26 vials
Official record key
drug-enforcement:D-0531-2025

Official wording

Reason: Marketed Without an Approved NDA/ANDA

Code information: Lot P-24-1; Exp. 02/28/2027

Distribution pattern: NY, NJ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA