TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per c...

FDA Recall #D-0531-2025 — Class II — May 30, 2025

Recall #D-0531-2025 Date: May 30, 2025 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

Advanced Pharmaceutical Technology, Inc. — Elmsford, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

26 vials

Distribution

NY, NJ

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated