Drug Enforcement D-0531-2025

Marketed Without an Approved NDA/ANDA

Status

Ongoing

Classification

Class II

Report Date

July 2, 2025

Termination Date

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Product Information

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
Product quantity
26 vials
Reason for recall
Marketed Without an Approved NDA/ANDA
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
NY, NJ

Location & Firm

Recalling firm
Advanced Pharmaceutical Technology, Inc.
Address
132 S Central Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0531-2025
Event ID
96981
Recall initiation date
May 30, 2025
Center classification date
July 16, 2025
Code info
Lot P-24-1; Exp. 02/28/2027
More code info
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