TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical T
Summary
The FDA issued a Class II for TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Ma by Advanced Pharmaceutical Technology, Inc.. Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets..
Details
Source
Drug Recall
External ID
D-0258-2026
Action Date
2026-01-21
Status
Ongoing
Category
drug
Product Description
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lot/Code Info: Lot #: P-22-3, Exp 06-2027
Quantity Affected: 22,843 pellets
Reason for Recall
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Distribution
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-03
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 79 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-0258-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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