TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscula
Summary
The FDA issued a Class II for TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul by Advanced Pharmaceutical Technology, Inc.. Reason: Marketed Without an Approved NDA/ANDA.
Details
Source
Drug Recall
External ID
D-0531-2025
Action Date
2025-07-02
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot P-24-1; Exp. 02/28/2027
Quantity Affected: 26 vials
Reason for Recall
Marketed Without an Approved NDA/ANDA
Distribution
NY, NJ
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-30
Company
Elmsford, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 57 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Advanced Pharmaceutical Technology, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advanced Pharmaceutical Technology, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advanced Pharmaceutical Technology, Inc. have FDA actions?
Advanced Pharmaceutical Technology, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0531-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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